The Primary-Secondary Care Partnership to Improve Outcomes in Chronic Kidney Disease (PSP-CKD) Study: A Cluster Randomized Trial in Primary Care.

BACKGROUND: Most patients with CKD are managed in the community. Whether nurse-led CKD management programs improve outcomes in patients with CKD in primary care is unclear. METHODS: To assess the effect of such a program on the rate of renal function decline in patients with CKD (stages 3-5) in primary care in the United Kingdom, we conducted a cluster randomized trial, the Primary-Secondary Care Partnership to Improve Outcomes in Chronic Kidney Disease study. A software program designed for the study created a data file of patients with CKD in participating practices. In 23 intervention practices (11,651 patients), a CKD nurse practitioner worked with nominated practice leads to interpret the data file and implement guideline-based patient-level CKD management interventions. The 23 control practices (11,706 patients) received a data file but otherwise, continued usual CKD care. The primary outcome was defined at the cluster (practice) level as the change from baseline of the mean eGFR of the patients with CKD at 6-month intervals up to 42 months. Secondary outcomes included numbers of patients coded for CKD, mean BP, numbers of patients achieving National Institute for Health and Care Excellence BP targets for CKD, and proteinuria measurement. RESULTS: After 42 months, eGFR did not differ significantly between control and intervention groups. CKD- and proteinuria-related coding improved significantly along with the number of patients achieving BP targets in the intervention group versus usual care. CONCLUSIONS: CKD management programs in primary care may not slow progression of CKD, but they may significantly improve processes of care and potentially decrease the cardiovascular disease burden in CKD and related costs.

Sézary Syndrome Presenting With Renal Involvement.

Sézary syndrome is a rare aggressive leukemic variant of primary cutaneous T-cell lymphoma, typically presenting with erythroderma, lymphadenopathy, and an atypical clonal T-cell population. Though it often involves the spleen and liver, we report a case of Sézary syndrome with renal involvement that was treated successfully. Visceral involvement confers a poor prognosis requiring systemic treatment. The patient we describe was a 66-year-old man who was referred from Dermatology services for deteriorating kidney function. Polymerase chain reaction of genomic DNA from skin and kidney biopsies confirmed a clonal T-cell population matching a population isolated in peripheral blood. The patient was treated initially with alemtuzumab, which led to a significant improvement in kidney function, and he has subsequently received a successful allogeneic stem cell transplant. This case represents a rare cause of decreased kidney function and highlights the role of biopsy in patients with suspected Sézary syndrome.

Exploring access to end of life care for ethnic minorities with end stage kidney disease through recruitment in action research.

BACKGROUND: Variation in provision of palliative care in kidney services and practitioner concerns to provide equitable access led to the development of this study which focussed on the perspectives of South Asian patients and their care providers. As people with a South Asian background experience a higher risk of Type 2 Diabetes (T2DM) and end stage kidney failure (ESKF) compared to the majority population but wait longer for a transplant, there is a need for end of life care to be accessible for this group of patients. Furthermore because non English speakers and people at end of life are often excluded from research there is a dearth of research evidence with which to inform service improvement. This paper aims to explore issues relating to the process of recruitment of patients for a research project which contribute to our understanding of access to end of life care for ethnic minority patients in the kidney setting. METHODS: The study employed an action research methodology with interviews and focus groups to capture and reflect on the process of engaging with South Asian patients about end of life care. Researchers and kidney care clinicians on four NHS sites in the UK recruited South Asian patients with ESKF who were requiring end of life care to take part in individual interviews; and other clinicians who provided care to South Asian kidney patients at end of life to take part in focus groups exploring end of life care issues. In action research planning, action and evaluation are interlinked and data were analysed with emergent themes fed back to care providers through the research cycle. Reflections on the process of patient recruitment generated focus group discussions about access which were analysed thematically and reported here. RESULTS: Sixteen patients were recruited to interview and 45 different care providers took part in 14 focus groups across the sites. The process of recruiting patients to interview and subsequent focus group data highlighted some of the key issues concerning access to end of life care. These were: the identification of patients approaching end of life; and their awareness of end of life care; language barriers and informal carers' roles in mediating communication; and contrasting cultures in end of life kidney care. CONCLUSIONS: Reflection on the process of recruitment in this action research study provided insight into the complex scenario of end of life in kidney care. Some of the emerging issues such as the difficulty identifying patients are likely to be common across all patient groups, whilst others concerning language barriers and third party communication are more specific to ethnic minorities. A focus on South Asian ethnicity contributes to better understanding of patient perspectives and generic concepts as well as access to end of life kidney care for this group of patients in the UK. Action research was a useful methodology for achieving this and for informing future research to include informal carers and other ethnic groups.

The use of culturally adapted and translated depression screening questionnaires with South Asian haemodialysis patients in England.

BACKGROUND: Depression is common amongst patients receiving haemodialysis (HD). Assessment and intervention when faced with language and cultural barriers is challenging. To support clinician decisions, we conducted a cross-sectional study to assess the use of culturally adapted and translated versions of commonly-used depression screening questionnaires with South Asian patients receiving HD in England. METHODS: Patients completed adapted versions of the Patient Health Questionnaire (PHQ-9), the Centre for Epidemiological Studies Depression Scale Revised (CESD-R), and the Beck Depression Inventory II (BDI-II). All questionnaires were available in Gujarati, Punjabi, Urdu, and Bengali. A comparative sample of white-Europeans completed the questionnaires in English. The research was based across 9 National Health Service (NHS) Trusts in England. Structural validity of translated questionnaires was assessed using confirmatory factor analysis. Diagnostic accuracy was explored in a subgroup of South Asians against ICD-10 categories using the Clinical Interview Schedule Revised (CIS-R) with receiver operating curve (ROC) analysis. RESULTS: 229 South Asian and 120 white-European HD patients participated. A single latent depression factor largely accounted for the correlations between items of the PHQ-9, CESD-R and BDI-II. Issues with measurement equivalence implied that scores on the translations may not be comparable with the English language versions. Against CIS-R based ICD-10 diagnosis of depression, sensitivity was modest across scales (50-66.7%). Specificity was higher (81.3-93.8%). Alternative screening cut-offs did not improve positive predictive values. CONCLUSIONS: Culturally adapted translations of depression screening questionnaires are useful to explore symptom endorsement amongst South Asian patients. However, data indicate that standard cut-off scores may not be appropriate to classify symptom severity. Use of the CIS-R algorithms for optimal case identification requires further exploration in this setting. Strategies to encourage recruitment of under-represented groups in renal research are also warranted, especially for in-depth discussions related to psychological care needs.

UK Renal Registry 12th Annual Report (December 2009): chapter 8: adequacy of haemodialysis in UK renal centres in 2008: national and centre-specific analyses.

BACKGROUND: Outcome in patients treated with haemodialysis (HD) is influenced by the delivered dose of dialysis. The UK Renal Association (RA) publishes Clinical Practice Guidelines which include recommendations for dialysis dose. The urea reduction ratio (URR) is a widely used measure of dialysis dose. AIM: To determine the extent to which patients received the recommended dose of HD in the UK. METHODS: Seventy-two renal centres in the UK submit data electronically to the UK Renal Registry (UKRR). Two groups of patients were included in the analyses: the prevalent patient population on 31st December 2008 and the incident patient population for 2008. Centres returning data on <50% of their patient population were excluded from centre-specific comparisons. RESULTS: Data regarding URR were available from 62 renal centres in the UK. Fifty-one centres provided URR data on more than 90% of prevalent patients. There has been an increase from 56% in 1998 to 83% in 2008 in the proportion of patients in the UK who met the UK Clinical Practice Guideline for URR (>65%). There was considerable variation from one centre to another, with 9 centres attaining the RA clinical practice guideline in >90% of patients and 5 centres attaining the standard in <70% of patients. The HD dose (URR) delivered to patients who had just started dialysis treatment was lower than that of patients who had been treated for longer and increased further with time. CONCLUSIONS: The delivered dose of HD for patients with established renal failure has increased over 10 years. Whilst the large majority of patients in the UK achieved the target URR there was considerable variation between centres in the percentage of patients achieving this.

UK Renal Registry 12th Annual Report (December 2009): chapter 10: biochemistry profile of patients receiving dialysis in the UK in 2008: national and centre-specific analyses.

INTRODUCTION: The UK Renal Association Clinical Practice Guidelines include clinical performance measures for biochemical parameters in dialysis patients [1]. The UK Renal Registry (UKRR) annually audits dialysis centre performance against these measures as part of its role in promoting continuous quality improvement. METHODS: Cross sectional performance analyses were undertaken to compare dialysis centre achievement of clinical performance measures for prevalent haemodialysis (HD) and peritoneal dialysis (PD) cohorts in 2008. The biochemical variables studied were phosphate, adjusted calcium, calcium phosphate product, parathyroid hormone, bicarbonate, total cholesterol and HbA1c. In addition, longitudinal analyses were performed (2000-2008) to show changes in achievement of clinical performance measures over time. RESULTS: Serum phosphate was between 1.1 and 1.8 mmol/L in 55% of HD and 64% of PD patients, which was similar to 2007. There was a fall in overall mean phosphate concentration to 1.55 mmol/L. A revised adjusted serum calcium target of 2.2-2.5 mmol/L was achieved by 63% of HD and 65% of PD patients. For comparison, the previous target of 2.2-2.6 mmol/L was achieved by 74% and 78% respectively, a figure little changed since 2005. The downward trend in serum calcium results evident for the previous nine years appears to have halted. The calcium phosphate target of <4.8 mmol(2)/L(2) was achieved by 84% of HD and 87% of PD patients, continuing the steady improvement over the past nine years and reflecting the downward trend in phosphate results. As in previous years, a minority of patients achieved the PTH target range of 16-32 pmol/L and there was considerable heterogeneity between centres. Although analytical and biological variability may have contributed to this, centres achieving the standards relating to one mineral parameter tended to achieve the standards in others suggesting that treatment factors were also relevant. The audit measure for bicarbonate was achieved in 71% of HD and 82% of PD patients. Eighty-five percent of HD patients and 69% of PD patients achieved a value for total cholesterol <5 mmol/L. This was the first year that HbA1c has been audited. Overall, 43% of diabetic dialysis patients exceeded the target of 7.5% HbA1c and there was considerable variation between centres. CONCLUSION: There is wide variation between centres in attainment of biochemical performance measures. There is some evidence in bone mineral metabolism that centres performing well in one variable are more likely to also meet the other standards. The inter-centre variation may be explained in part by laboratory practices and case mix but probably also represents variation in practice and in effectiveness of processes of care. Apart from glycaemic control there are a number of analytical and clinical factors that affect HbA1c that would be worthy of further investigation as a cause of variability.

Sodium bicarbonate to improve physical function in patients over 60 years with advanced chronic kidney disease: the BiCARB RCT.

BACKGROUND: Advanced chronic kidney disease is common in older people and is frequently accompanied by metabolic acidosis. Oral sodium bicarbonate is used to treat this acidosis, but evidence is lacking on whether or not this provides a net gain in health or quality of life for older people. OBJECTIVES: The objectives were to determine whether or not oral bicarbonate therapy improves physical function, quality of life, markers of renal function, bone turnover and vascular health compared with placebo in older people with chronic kidney disease and mild acidosis; to assess the safety of oral bicarbonate; and to establish whether or not oral bicarbonate therapy is cost-effective in this setting. DESIGN: A parallel-group, double-blind, placebo-controlled randomised trial. SETTING: The setting was nephrology and geriatric medicine outpatient departments in 27 UK hospitals. PARTICIPANTS: Participants were adults aged ≥ 60 years with advanced chronic kidney disease (glomerular filtration rate category 4 or 5, not on dialysis) with a serum bicarbonate concentration of < 22 mmol/l. INTERVENTIONS: Eligible participants were randomised 1 : 1 to oral sodium bicarbonate or matching placebo. Dosing started at 500 mg three times daily, increasing to 1 g three times daily if the serum bicarbonate concentration was < 22 mmol/l at 3 months. MAIN OUTCOME MEASURES: The primary outcome was the between-group difference in the Short Physical Performance Battery score at 12 months, adjusted for baseline. Other outcome measures included generic and disease-specific health-related quality of life, anthropometry, 6-minute walk speed, grip strength, renal function, markers of bone turnover, blood pressure and brain natriuretic peptide. All adverse events were recorded, including commencement of renal replacement therapy. For the health economic analysis, the incremental cost per quality-adjusted life-year was the main outcome. RESULTS: In total, 300 participants were randomised, 152 to bicarbonate and 148 to placebo. The mean age of participants was 74 years and 86 (29%) were female. Adherence to study medication was 73% in both groups. A total of 220 (73%) participants were assessed at the 12-month visit. No significant treatment effect was evident for the primary outcome of the between-group difference in the Short Physical Performance Battery score at 12 months (-0.4 points, 95% confidence interval -0.9 to 0.1 points; p = 0.15). No significant treatment benefit was seen for any of the secondary outcomes. Adverse events were more frequent in the bicarbonate arm (457 vs. 400). Time to commencement of renal replacement therapy was similar in both groups (hazard ratio 1.22, 95% confidence interval 0.74 to 2.02; p = 0.43). Health economic analysis showed higher costs and lower quality of life in the bicarbonate arm at 1 year, with additional costs of £564 (95% confidence interval £88 to £1154) and a quality-adjusted life-year difference of -0.05 (95% confidence interval -0.08 to -0.01); placebo dominated bicarbonate under all sensitivity analyses for incremental cost-effectiveness. LIMITATIONS: The trial population was predominantly white and male, limiting generalisability. The increment in serum bicarbonate concentrations achieved was small and a benefit from larger doses of bicarbonate cannot be excluded. CONCLUSIONS: Oral sodium bicarbonate did not improve a range of health measures in people aged ≥ 60 years with chronic kidney disease category 4 or 5 and mild acidosis, and is unlikely to be cost-effective for use in the NHS in this patient group. Once other current trials of bicarbonate therapy in chronic kidney disease are complete, an individual participant meta-analysis would be helpful to determine which subgroups, if any, are more likely to benefit and which treatment regimens are more beneficial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN09486651 and EudraCT 2011-005271-16. The systematic review is registered as PROSPERO CRD42018112908. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 27. See the NIHR Journals Library website for further project information.

Patients with advanced chronic kidney disease often have excessive levels of acid in their blood (acidosis). Acidosis has been associated with a range of other problems that particularly affect patients with chronic kidney disease, including weaker muscles, weaker bones, worse blood vessel health and kidney disease that worsens more quickly. For decades, acidosis has been treated with sodium bicarbonate tablets (the ingredient found in baking soda) to neutralise the excess acid. However, sodium bicarbonate is awkward to take, may cause side effects and may increase blood pressure. To clarify whether or not sodium bicarbonate caused an overall improvement in health, we carried out a study involving 300 people aged ≥ 60 years with advanced chronic kidney disease and mild acidosis. Half received sodium bicarbonate capsules and half received dummy capsules (placebo), for up to 2 years. The treatments were chosen randomly by a computer and the participants, their doctors and the researchers were not aware of the treatment received until the end of the study. We measured physical function (walking speed, ability to stand from a chair, balance) alongside quality of life, kidney function, bone and blood vessel health, side effects and health service use over 2 years. We found that sodium bicarbonate did not improve physical function or quality of life compared with placebo. Sodium bicarbonate also did not improve kidney function, bone health or blood vessel health compared with placebo. More people in the sodium bicarbonate group than in the placebo group had side effects, although blood pressure was the same in both groups. Health-care costs were higher in the sodium bicarbonate group than in the placebo group. We conclude that oral sodium bicarbonate did not significantly improve health measures compared with placebo for older people (aged ≥ 60 years) with advanced chronic kidney disease associated with mild acidosis.

UK Renal Registry 11th Annual Report (December 2008): Chapter 10 Biochemistry profile of patients receiving dialysis in the UK in 2007: national and centre-specific analyses.

INTRODUCTION: The UK Renal Association Clinical Practice Guidelines include clinical performance measures for biochemical parameters in dialysis patients [1]. The UK Renal Registry (UKRR) annually audits dialysis centre performance against these measures as part of its role in promoting continuous quality improvement. METHODS: Cross sectional performance analyses were undertaken to compare dialysis centre achievement of clinical audit measures for prevalent haemodialysis (HD) and peritoneal dialysis (PD) cohorts in 2007. The biochemical variables studied were phosphate, adjusted calcium, parathyroid hormone, bicarbonate and total cholesterol. In addition longitudinal analyses were performed (2000-2007) to show changes in achievement of clinical performance measures over time. RESULTS: Serum phosphate was between 1.1-1.8 mmol/L in 53% of HD and 64% of PD patients. Since 2003 there has been annual improvement in phosphate control for both HD and PD patients, largely through a reduction in phosphate >1.8 mmol/L. PD patients this year also showed a reduction in the percentage with a low phosphate. Adjusted calcium was between 2.2-2.6 mmol/L in 73% of HD and 78% of PD patients. Parathyroid hormone was between 16-32 pmol/L in 25% of HD and 27% of PD patients. The audit measure for bicarbonate was achieved in 71% of HD and 50% of PD patients. There was inter-centre variation for all variables studied. CONCLUSIONS: The UKRR consistently demonstrates inter-centre variation in achievement of biochemical clinical audit measures. Understanding the causes of this variation is an important part of improving the care of dialysis patients in the UK.

Serum calcium, phosphate, parathyroid hormone, albumin, aluminium and cholesterol achievement on replacement therapy (chapter 9).

In the UK, there is a continuing year-on-year trend towards improvement in serum phosphate control in dialysis patients although overall it still remains poor. The Renal Association (RA) target (<1.8 mmol/l) was achieved in 65% of patients overall, (71% of peritoneal dialysis (PD) patients, 63% of haemo dialysis (HD) patients). Seventy-six percent of UK dialysis patients achieve a corrected calcium concentration within the RA target range. As with serum phosphate, there is a trend of continuing year-on-year improvement. Nearly two-thirds (69%) of patients achieve a calcium x phosphate product within the KDOQI guidelines (<4.4 mmol(2)/l(2)): again, achievement seems to have improved year-on-year. Control was better in PD patients compared with HD patients (73% vs 67% achieving the standard). There remains large between-centre variation in the ability of renal centres to achieve the UK RA target for plasma parathyroid hormone (PTH). As seen in previous years, overall achievement was poor (median 63%, range 47-92% compliance with the standard). Most transplant patients achieve good phosphate and calcium control (99%, range 95-100%) and the percentage of patients achieving serum calcium concentrations within the target range was 84% (range 43-97%). Nearly all (99%) of transplant patients achieved calcium x phosphate product concentrations within the KDOQI target range. There would appear to be wide variation in clinical practice with respect to aluminium monitoring with a suggestion that few centres are following current UK, RA guidelines. Overall in the UK, 83% of HD, 70% of PD and 62% of transplant patients achieve a total cholesterol concentration <5 mmol/l. The percentage of patients with cholesterol <5 mmol/l has increased significantly year-on-year in all three modalities.

Management of anaemia in haemodialysis and peritoneal dialysis patients (chapter 8).

Forty-one percent of UK patients commence RRT with an Hb < 10.0 g/dl. The mean Hb at commencement of RRT is 10.3 g/dl. Eighty-five percent of patients on dialysis in the UK have an Hb > or = 10.0 g/dl by 6 months after commencement of RRT. The median Hb on haemodialysis in the UK is 11.8 g/dl with an IQR of 10.7-12.8 g/dl. Eighty-six percent of haemodialysis patients in the UK have a Hb > or = 10.0 g/dl. The median Hb on peritoneal dialysis in the UK is 12.0 g/dl with an IQR of 11.0-12.9 g/dl. Ninety percent of peritoneal dialysis patients in the UK have an Hb > or = 10.0 g/dl. In the UK, 49% of patients on PD and 48% of patients on haemodialysis have an Hb between 10.5-12.5 g/dl. The median ferritin in UK haemodialysis patients is 413 microg/l (IQR 262-623), 95% of UK haemodialysis patients have a ferritin > or =100 microg/l. The median ferritin in UK PD patients is 256 microg/l (IQR 147-421), 86% of UK peritoneal dialysis patients have a ferritin > or = 100 microg/l. A higher proportion of HD patients than PD patients receive ESA therapy (88% vs 76%). The ESA dose is higher for HD than PD patients (9204 vs 6080 IU/week).

Time, timing, talking and training: findings from an exploratory action research study to improve quality of end of life care for minority ethnic kidney patients.

Background. With an ageing and increasingly diverse population at risk from rising levels of obesity, diabetes and cardiovascular disease, including kidney complications, there is a need to provide quality care at all stages in the care pathway including at the end of life and to all patients. Aim. This study purposively explored South Asian patients' experiences of kidney end of life care to understand how services can be delivered in a way that meets diverse patient needs. Methods. Within an action research design 14 focus groups (45 care providers) of kidney care providers discussed the recruitment and analysis of individual interviews with 16 South Asian kidney patients (eight men, eight women). Emergent themes from the focus groups were analysed thematically. The research took place at four UK centres providing kidney care to diverse populations: West London, Luton, Leicester and Bradford. Results. Key themes related to time and the timing of discussions about end of life care and the factors that place limitations on patients and providers in talking about end of life care. Lack of time and confidence of nurses in areas of kidney care, individual attitudes and workforce composition influence whether and how patients have access to end of life care through kidney services. Conclusion. Training, team work and time to discuss overarching issues (including timing and communication about end of life) with colleagues could support service providers to facilitate access and delivery of end of life care to this group of patients.

The second United Kingdom Heart and Renal Protection (UK-HARP-II) Study: a randomized controlled study of the biochemical safety and efficacy of adding ezetimibe to simvastatin as initial therapy among patients with CKD.

BACKGROUND: Evaluating the effects of decreasing low-density lipoprotein (LDL) cholesterol levels requires large randomized trials. In preparation for such a trial, we assessed the biochemical efficacy, safety, and tolerability of adding ezetimibe, 10 mg/d, to simvastatin, 20 mg/d, as initial therapy for such patients. METHODS: Two hundred three patients (152 predialysis patients with creatinine levels > or = 1.7 mg/dL [> or = 150 micromol/L], 18 patients on peritoneal dialysis therapy, and 33 patients on hemodialysis therapy) were randomly assigned to the administration of simvastatin, 20 mg/d, plus ezetimibe, 10 mg/d; or simvastatin, 20 mg, plus placebo ezetimibe daily. RESULTS: After 6 months, allocation to simvastatin monotherapy was associated with a 31-mg/dL (0.8-mmol/L) decrease in nonfasting LDL cholesterol levels compared with baseline. Allocation to simvastatin plus ezetimibe produced an additional 18-mg/dL (0.47-mmol/L) decrease in LDL cholesterol level, representing an incremental 21% reduction over that achieved with simvastatin monotherapy (P < 0.0001). There were no statistically significant effects of the addition of ezetimibe to simvastatin on triglyceride or high-density lipoprotein cholesterol levels. Ezetimibe was not associated with an excess risk of abnormal liver function test results or of elevated creatine kinase levels and did not impair absorption of fat-soluble vitamins. There were no serious adverse events caused by study treatment. CONCLUSION: This 6-month study shows that the addition of ezetimibe to simvastatin, 20 mg/d, as initial therapy for patients with chronic kidney disease was well tolerated and produced an additional 21% decrease in LDL cholesterol levels. The clinical efficacy and safety of combination therapy in this population are now being assessed in a large randomized trial.

Prescription Rates of Cardiovascular Medications in a Large UK Primary Care Chronic Kidney Disease Cohort.

BACKGROUND AND AIMS: Chronic kidney disease (CKD) is associated with increased cardiovascular (CV) risk. Guidelines have suggested the universal use of statins in CKD but aspirin's role is less well defined. The aim of this study was to determine prescription rates for statins and aspirin in a UK-based CKD cohort and to establish factors that influenced prescription rates. METHODS: We used data from a UK primary care CKD cohort to study rates of prescription of statins and aspirin. Simple rates were initially calculated. Binary logistic regression was utilized with either statin or aspirin prescription as the outcome variable and covariates including demographic details and comorbidities. RESULTS: There were 31,056 individuals in the cohort with at least one estimated glomerular filtration rate (eGFR) of <60 ml/min/1.73 m2, and 65.1% individuals had 2 eGFR results <60 ml/min/1.73 m2 more than 3 months apart. Mean eGFR at baseline was 51.1 ml/min/1.73 m2 (SD 9.1), and 64.9% had a diagnosis of hypertension (HTN), 18.8% had diabetes mellitus (DM) and 29.8% a history of CV disease. Statins were prescribed to 14,972 (48.2%) and aspirin to 11,023 (35.5%). The regression model suggested that CV disease, HTN and DM influenced the prescriptions of statins and aspirin but overall CKD stage, calculated by either eGFR or proteinuria, did not. CONCLUSIONS: Prescriptions of statins and aspirin in CKD is based more on the presence of comorbidities than the CKD severity. Further physician and patient education of the increased CV risk associated with CKD and its suitability for CV medication intervention is required.

First United Kingdom Heart and Renal Protection (UK-HARP-I) study: biochemical efficacy and safety of simvastatin and safety of low-dose aspirin in chronic kidney disease.

BACKGROUND: Patients with chronic kidney disease are at increased risk for cardiovascular disease, but the efficacy and safety of simvastatin and aspirin are unknown in this patient group. METHODS: Patients were randomly assigned in a 2 x 2 factorial design to the administration of: (1) 20 mg of simvastatin daily versus matching placebo, and (2) 100 mg of modified-release aspirin daily versus matching placebo. RESULTS: Overall, 448 patients with chronic kidney disease were randomly assigned (242 predialysis patients with a creatinine level > or = 1.7 mg/dL [> or =150 micromol/L], 73 patients on dialysis therapy, and 133 patients with a functioning transplant). Compliance with study treatments was 80% at 12 months. Allocation to treatment with 100 mg of aspirin daily was not associated with an excess of major bleeds (aspirin, 4 of 225 patients [2%] versus placebo, 6 of 223 patients [3%]; P = not significant [NS]), although there was a 3-fold excess of minor bleeds (34 of 225 [15%] versus 12 of 223 patients [5%]; P = 0.001). Among those with predialysis renal failure or a functioning transplant at baseline, aspirin did not increase the number of patients who progressed to dialysis therapy (7 of 187 [4%] versus 6 of 188 patients [3%]; P = NS) or experienced a greater than 20% increase in creatinine level (63 of 187 patients [34%] versus 56 of 188 patients [30%]; P = NS). After 12 months of follow-up, allocation to 20 mg of simvastatin daily reduced nonfasting total cholesterol levels by 18% (simvastatin, 163 mg/dL [4.22 mmol/L] versus placebo, 196 mg/dL [5.08 mmol/L]; P < 0.0001), directly measured low-density lipoprotein cholesterol levels by 24% (89 mg/dL [2.31 mmol/L] versus 114 mg/dL [2.96 mmol/L]; P < 0.0001), and triglyceride levels by 13% (166 mg/dL [1.87 mmol/L] versus 186 mg/dL [2.10 mmol/L]; P < 0.01), but there was no significant effect on high-density lipoprotein cholesterol levels (2% increase; P = NS). Allocation to simvastatin therapy was not associated with excess risk for abnormal liver function test results or elevated creatine kinase levels. CONCLUSION: During a 1-year treatment period, simvastatin, 20 mg/d, produced a sustained reduction of approximately one quarter in low-density lipoprotein cholesterol levels, with no evidence of toxicity, and aspirin, 100 mg/d, did not substantially increase the risk for a major bleeding episode. Much larger trials are now needed to assess whether these treatments can prevent vascular events.

Establishing a supportive care register improves end-of-life care for patients with advanced chronic kidney disease.

BACKGROUND: End-of-life care for patients with advanced chronic kidney disease (CKD) is recognised as an important area for improvement. These patients have a significant mortality and, although some is unpredictable, there is a role for the nephrology multi-disciplinary team (MDT) and palliative care physicians to engage in advance care planning and support patients to discuss their preferences. METHODS: Retrospective and prospective data were obtained to conduct a comparison observational study to assess the impact of introducing a supportive care register on the end-of-life care for patients with advanced CKD. An electronic supportive care register was implemented. This required a programme of multi-disciplinary staff education, collaborative working with Palliative Care to establish renal-specific protocols and dissemination activities. The impact of the intervention was assessed by analysing all deaths in two six-month periods where all those with an eGFR <15 ml/min/1.73 m(2) at the time of their death were included. RESULTS: A total of 91 patients were included. Post-intervention, there was a 25.4% (95% CI: 6.5-44.3%, p = 0.008) improvement in patients having a documented discussion about end-of-life planning. There was also a 19.7% (95% CI: 4.0-35.5%, p = 0.01) improvement in establishing the place of death. All patients who expressed a preferred place of death died there. The intervention increased engagement with the wider MDT and led to significant improvements in access to specialist palliative care services. CONCLUSIONS: These results show that the interventions implemented to introduce a supportive care register resulted in meaningful improvements to the end-of-life care for patients in our region with advanced CKD. © 2015 S. Karger AG, Basel.

Communication as care at end of life: an emerging issue from an exploratory action research study of renal end-of-life care for ethnic minorities in the UK.

South Asian people have a higher risk of developing kidney disease, are disproportionately represented in the patient population requiring renal replacement therapy and wait longer to receive a kidney transplant, compared with white Europeans. As a result, there is a demand for end-of-life care, which meets the needs of this group of patients. Providing end-of-life care to patients from different cultures is a challenge for renal services as there can be barriers to communication in the form of language, delegated decision-making within families and reluctance to discuss death. To explore end-of-life care for South Asians with kidney disease, 16 interviews with patients and 14 focus groups with care providers were conducted at four research sites in the UK with large South Asian populations. Using an action research design the data were analysed thematically and fed back to inform the research in a cyclical manner. If patients are not fully aware of their condition or of what end-of-life care is, it is less likely that they will be able to be involved in decision-making about their care and this is compounded where there are communication barriers. Variations in care provider awareness and experience of providing end-of-life care to South Asian patients, in turn, contributes to lack of patient awareness of end-of-life care. Communication as care at the end of life should be explored further. Researching the South Asian patient experience of end of life highlights many relevant and generalisable issues.

Iron-magnesium hydroxycarbonate (fermagate): a novel non-calcium-containing phosphate binder for the treatment of hyperphosphatemia in chronic hemodialysis patients.

BACKGROUND AND OBJECTIVES: This phase II study tested the safety and efficacy of fermagate, a calcium-free iron and magnesium hydroxycarbonate binder, for treating hyperphosphatemia in hemodialysis patients. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A randomized, double-blind, three-arm, parallel-group study compared two doses of fermagate (1 g three times daily or 2 g three times daily with placebo). Sixty-three patients who had been on a stable hemodialysis regimen for > or =3 mo were randomized to the treatment phase. Study medication was administered three times daily just before meals for 21 d. The primary endpoint was reduction in serum phosphate over this period. RESULTS: In the intention-to-treat analysis, mean baseline serum phosphate was 2.16 mmol/L. The fermagate 1- and 2-g three-times-daily treatment arms were associated with statistical reductions in mean serum phosphate to 1.71 and 1.47 mmol/L, respectively. Adverse event (AE) incidence in the 1-g fermagate arm was statistically comparable to the placebo group. The 2-g arm was associated with a statistically higher number of patients reporting AEs than the 1-g arm, particularly gastrointestinal AEs, as well as a higher number of discontinuations, complicating interpretation of this dose's efficacy. Both doses were associated with elevations of prehemodialysis serum magnesium levels. CONCLUSIONS: The efficacy and tolerability of fermagate were dose dependent. Fermagate showed promising efficacy in the treatment of hyperphosphatemia in chronic hemodialysis patients as compared with placebo in this initial phase II study. The optimal balance between efficacy and tolerability needs to be determined from future dose-titration studies, or fixed-dose comparisons of more doses.