Changes in the epidemiology of kidney replacement therapy across Europe in 2020 - the first year of the COVID-19 pandemic: an ERA Registry study.

BACKGROUND: In 2020, the COVID-19 pandemic caused disruptions in kidney replacement therapy (KRT) services worldwide. The aim of this study was to assess the effect of the COVID-19 pandemic in 2020 on the incidence of KRT, kidney transplantation activity, mortality and prevalence of KRT across Europe. METHODS: Patients receiving KRT were included from 17 countries providing data to the European Renal Association Registry. The epidemiology of KRT in 2020 was compared with average data from the period 2017-2019. Also changes occurring during the first and second wave of the pandemic were explored. RESULTS: The incidence of KRT was 6.2% lower in 2020 compared with 2017-2019, with the lowest point (-22.7%) during the first wave in April. The decrease varied across countries, was smaller in males (-5.2%) than in females (-8.2%), and was moderate for peritoneal dialysis (-3.7%) and haemodialysis (-5.4%), but substantial for pre-emptive kidney transplantation (-23.6%). The kidney transplantation rate decreased by 22.5%, reaching a nadir of -80.1% during the first wave, and most for living donor kidney transplants (-30.5%). While in most countries the kidney transplantation rate decreased, in the Nordic/Baltic countries and Greece there was no clear decline. In dialysis patients, mortality increased by 11.4%, and was highest in those aged 65-74 years (16.1%), in those with diabetes as primary renal disease (15.1%), and in those on haemodialysis (12.4%). In transplant recipients, the mortality was 25.8% higher, but there were no subgroups that stood out. In contrast to the rising prevalence of KRT observed over the past decades across Europe, the prevalence at the end of 2020 (N=317787) resembled that of 2019 (N=317077). CONCLUSION: The COVID-19 pandemic has had a substantial impact on the incidence of KRT, kidney transplant activity, mortality of KRT, and prevalence of KRT in Europe with variations across countries.

COVID-19 in transplant recipients: The Spanish experience.

We report the nationwide experience with solid organ transplant (SOT) and hematopoietic stem cell transplant (HSCT) recipients diagnosed with coronavirus disease 2019 (COVID-19) in Spain until 13 July 2020. We compiled information for 778 (423 kidney, 113 HSCT, 110 liver, 69 heart, 54 lung, 8 pancreas, 1 multivisceral) recipients. Median age at diagnosis was 61 years (interquartile range [IQR]: 52-70), and 66% were male. The incidence of COVID-19 in SOT recipients was two-fold higher compared to the Spanish general population. The median interval from transplantation was 59 months (IQR: 18-131). Infection was hospital-acquired in 13% of cases. No donor-derived COVID-19 was suspected. Most patients (89%) were admitted to the hospital. Therapies included hydroxychloroquine (84%), azithromycin (53%), protease inhibitors (37%), and interferon-ß (5%), whereas immunomodulation was based on corticosteroids (41%) and tocilizumab (21%). Adjustment of immunosuppression was performed in 85% of patients. At the time of analysis, complete follow-up was available from 652 patients. Acute respiratory distress syndrome occurred in 35% of patients. Ultimately, 174 (27%) patients died. In univariate analysis, risk factors for death were lung transplantation (odds ratio [OR]: 2.5; 95% CI: 1.4-4.6), age >60 years (OR: 3.7; 95% CI: 2.5-5.5), and hospital-acquired COVID-19 (OR: 3.0; 95% CI: 1.9-4.9).

Results from the ERA-EDTA Registry indicate a high mortality due to COVID-19 in dialysis patients and kidney transplant recipients across Europe.

The aim of this study was to investigate 28-day mortality after COVID-19 diagnosis in the European kidney replacement therapy population. In addition, we determined the role of patient characteristics, treatment factors, and country on mortality risk with the use of ERA-EDTA Registry data on patients receiving kidney replacement therapy in Europe from February 1, 2020, to April 30, 2020. Additional data on all patients with a diagnosis of COVID-19 were collected from 7 European countries encompassing 4298 patients. COVID-19-attributable mortality was calculated using propensity score-matched historic control data and after 28 days of follow-up was 20.0% (95% confidence interval 18.7%-21.4%) in 3285 patients receiving dialysis and 19.9% (17.5%-22.5%) in 1013 recipients of a transplant. We identified differences in COVID-19 mortality across countries, and an increased mortality risk in older patients receiving kidney replacement therapy and male patients receiving dialysis. In recipients of kidney transplants ≥75 years of age, 44.3% (35.7%-53.9%) did not survive COVID-19. Mortality risk was 1.28 (1.02-1.60) times higher in transplant recipients compared with matched dialysis patients. Thus, the pandemic has had a substantial effect on mortality in patients receiving kidney replacement therapy, a highly vulnerable population due to underlying chronic kidney disease and a high prevalence of multimorbidity.

Personalized peritoneal dialysis prescription-beyond clinical or analytical values.

Traditionally, dialysis adequacy has been assessed primarily by determining the clearance of a single small solute, urea. Nevertheless, it has become increasingly evident that numerous other factors play a crucial role in the overall well-being, outcomes and quality of life of dialysis patients. Consequently, in recent years, there has been a notable paradigm shift in guidelines and recommendations regarding dialysis adequacy. This shift represents a departure from a narrow focus only on the removal of specific toxins, embracing a more holistic, person-centered approach. This new perspective underscores the critical importance of improving the well-being of individuals undergoing dialysis while simultaneously minimizing the overall treatment burden. It is based on a double focus on both clinical outcomes and a comprehensive patient experience. To achieve this, a person-centered approach must be embraced when devising care strategies for each individual. This requires a close collaboration between the healthcare team and the patient, facilitating an in-depth understanding of the patient's unique goals, priorities and preferences while striving for the highest quality of care during treatment. The aim of this publication is to address the existing evidence on this all-encompassing approach to treatment care for patients undergoing peritoneal dialysis and provide a concise overview to promote a deeper understanding of this person-centered approach.

Efficacy and safety of sucroferric oxyhydroxide in the treatment of hyperphosphataemia in chronic kidney disease in Asturias. FOSFASTUR study.

Alterations in bone and mineral metabolism are very common in chronic kidney disease (CKD). The increase in phosphate levels leads to bone disease, risk of calcification and greater mortality, so any strategy aimed at reducing them should be welcomed. The latest drug incorporated into the therapeutic arsenal to treat hyperphosphataemia in CKD is Sucroferric Oxyhydroxide (SFO). OBJECTIVE: To analyse the efficacy and safety of OSF in three cohorts of patients, one with advanced chronic kidney disease not on dialysis (CKD-NoD), another on peritoneal dialysis (PD) and the last on haemodialysis (HD), followed for six months. METHODS: A prospective, observational, multicentre study in clinical practice. Clinical and epidemiological variables were analysed. The evolution of parameters relating to alterations in bone and mineral metabolism and anaemia was analysed. RESULTS: Eighty-five patients were included in the study (62 ±â€¯12 years, 64% male, 34% diabetic), 25 with CKD-NoD, 25 on PD and lastly, 35 on HD. In 66 patients (78%), SFO was the first phosphate binder; in the other 19, SFO replaced a previous phosphate binder due to poor tolerance or efficacy. The initial dose of SFO was 964 ±â€¯323 mg/day. Overall, serum phosphate levels saw a significant reduction at three months of treatment (19.6%, P < 0.001). There were no differences in the efficacy of the drug when the different populations analysed were compared. Over the course of the study, there were no changes to levels of calcium, PTHi, ferritin, or the transferrin and haemoglobin saturation indices, although there was a tendency for the last two to increase. Twelve patients (14%) withdrew from follow-up, ten due to gastrointestinal adverse effects (primarily diarrhoea) and two were lost to follow-up (kidney transplant). The mean dose of the drug that the patients received increased over time, up to 1147 ±â€¯371 mg/day. CONCLUSIONS: SFO is an effective option for the treatment of hyperphosphataemia in patients with CKD both in the advanced phases of the disease and on dialysis. We found similar efficacy across the three groups analysed. The higher their baseline phosphate level, the greater the reduction in the serum levels. A notable reduction in phosphate levels can be achieved with doses of around 1000 mg/day. Diarrhoea was the most common side effect, although it generally was not significant.

Risk factors associated with valvular calcification in patients with chronic kidney disease. Analysis of NEFRONA study.

INTRODUCTION: Patients with chronic kidney disease (CKD) are at high risk of cardiovascular morbidity and mortality. Subclinical cardiac structural alterations have prognostic value in these patients. The aim was to analyse the prevalence of valvular calcification, the evolution and the relationship with different risk factors. MATERIAL AND METHODS: Part of the sample of the NEFRONA study was randomly selected. Aortic and mitral valve calcification were analysed in echocardiograms performed at the baseline visit and at 24 months. RESULTS: We included 397 patients, the estimated basal glomerular filtrate (eGFR) was 33 ml/min with significant decrease to 30.9 ml/min. There was an increase in the area of carotid and femoral plaque, as well as an increase in patients with aortic and mitral calcification at 24 months. A positive association of mitral calcification at 24 months with age, ankle-brachial index (ABI) and calcium-phosphorus product (CaxP) at baseline visit was observed, without association with eGFR. Aortic calcification at 24 months was positively associated with age, phosphorous and total carotid plaque area at baseline, with no relationship to eGFR. CONCLUSIONS: A significant prevalence of valvular calcification was observed in patients with CKD without known cardiovascular disease.Two-year progression was observed independently of the eGFR. Patients with higher risk of mitral valve calcification were those with older age, higher ABI and CaxP product. Patients with a higher risk of aortic calcification were those with older age, higher phosphorous levels and larger area of carotid plaque. Identifying these higher risk patients would help to avoid future cardiovascular events intensifying follow-ups.

[Risk factors associated with valvular calcification in patients with chronic kidney disease. Analysis of NEFRONA Study]. / Factores de riesgo asociados a la calcificación valvular en pacientes con enfermedad renal crónica. Análisis del Estudio Nefrona.

INTRODUCTION: Patients with chronic kidney disease (CKD) are at high risk of cardiovascular morbidity and mortality. Subclinical cardiac structural alterations have prognostic value in these patients. The aim was to analyse the prevalence of valvular calcification, the evolution and the relationship with different risk factors. MATERIAL AND METHODS: Part of the sample of the NEFRONA study was randomly selected. Aortic and mitral valve calcification were analysed in echocardiograms performed at the baseline visit and at 24 months. RESULTS: We included 397 patients, the estimated basal glomerular filtrate (eGFR) was 33ml/min with significant decrease to 30.9ml/min. There was an increase in the area of carotid and femoral plaque, as well as an increase in patients with aortic and mitral calcification at 24 months. A positive association of mitral calcification at 24 months with age, ankle-brachial index (ABI) and calcium-phosphorus product (CaxP) at baseline visit was observed, without association with eGFR. Aortic calcification at 24 months was positively associated with age, phosphorous and total carotid plaque area at baseline, with no relationship to eGFR. CONCLUSIONS: A significant prevalence of valvular calcification was observed in patients with CKD without known cardiovascular disease.Two-year progression was observed independently of the eGFR. Patients with higher risk of mitral valve calcification were those with older age, higher ABI and CaxP product. Patients with a higher risk of aortic calcification were those with older age, higher phosphorous levels and larger area of carotid plaque. Identifying these higher risk patients would help to avoid future cardiovascular events intensifying follow-ups.

Efficacy and safety of sucroferric oxyhydroxide in the treatment of hyperphosphataemia in chronic kidney disease. FOSFASTUR study. / Eficacia y seguridad de oxihidróxido sucroférrico en el tratamiento de la hiperfosforemia en la enfermedad renal crónica. Estudio FOSFASTUR.

INTRODUCTION: Alterations in bone and mineral metabolism are very common in chronic kidney disease (CKD). The increase in phosphate levels leads to bone disease, risk of calcification and greater mortality, so any strategy aimed at reducing them should be welcomed. The latest drug incorporated into the therapeutic arsenal to treat hyperphosphataemia in CKD is sucroferric oxyhydroxide (SFO). OBJECTIVE: To analyse the efficacy and safety of SFO in 3 cohorts of patients, one with advanced CKD not on dialysis, another on peritoneal dialysis and the last on haemodialysis, followed for 6 months. METHODS: A prospective, observational, multicentre study in clinical practice. Clinical and epidemiological variables were analysed. The evolution of parameters relating to alterations in bone and mineral metabolism and anaemia was analysed. RESULTS: Eighty-five patients were included in the study (62±12 years, 64% male, 34% diabetic), 25 with advanced CKD not on dialysis, 25 on peritoneal dialysis and lastly, 35 on haemodialysis. In 66 patients (78%), SFO was the first phosphate binder; in the other 19, SFO replaced a previous phosphate binder due to poor tolerance or efficacy. The initial dose of SFO was 964±323mg/day. Overall, serum phosphate levels saw a significant reduction at 3 months of treatment (19.6%; P<.001). There were no differences in the efficacy of the drug when the different populations analysed were compared. Over the course of the study, there were no changes to levels of calcium, PTHi, ferritin, transferrin saturation index or haemoglobin, although there was a tendency for the last 2 to increase. Twelve patients (14%) withdrew from follow-up, 10 due to gastrointestinal adverse effects (primarily diarrhoea) and 2 were lost to follow-up (kidney transplant). The mean dose of the drug that the patients received increased over time, up to 1,147±371mg/day. CONCLUSIONS: SFO is an effective option for the treatment of hyperphosphataemia in patients with CKD both in the advanced phases of the disease and on dialysis. We found similar efficacy across the 3 groups analysed. The higher their baseline phosphate level, the greater the reduction in the serum levels. A notable reduction in phosphate levels can be achieved with doses of around 1,000mg/day. Diarrhoea was the most common side effect, although it generally was not significant.

[SARS-CoV-2 infection in patients on renal replacement therapy. Report of the COVID-19 Registry of the Spanish Society of Nephrology (SEN)]. / Situación de la infección por SARS-CoV-2 en pacientes en tratamiento renal sustitutivo. Informe del Registro COVID-19 de la Sociedad Española de Nefrología (SEN).

INTRODUCTION: The recent appearance of the SARS-CoV-2 coronavirus pandemic has had a significant impact on the general population. Patients on renal replacement therapy (RRT) have not been unaware of this situation and due to their characteristics they are especially vulnerable. We present the results of the analysis of the COVID-19 Registry of the Spanish Society of Nephrology. MATERIAL AND METHODS: The Registry began operating on March 18th, 2020. It collects epidemiological variables, contagion and diagnosis data, signs and symptoms, treatments and outcomes. It is an online registry. Patients were diagnosed with SARS-CoV-2 infection based on the results of the PCR of the virus, carried out both in patients who had manifested compatible symptoms or had suspicious signs, as well as in those who had undergone screening after some contact acquainted with another patient. RESULTS: As of April 11, the Registry had data on 868 patients, from all the Autonomous Communities. The most represented form of RRT is in-center hemodialysis (ICH) followed by transplant patients. Symptoms are similar to the general population. A very high percentage (85%) required hospital admission, 8% in intensive care units. The most used treatments were hydroxychloroquine, lopinavir-ritonavir, and steroids. Mortality is high and reaches 23%; deceased patients were more frequently on ICH, developed pneumonia more frequently, and received less frequently lopinavir-ritonavir and steroids. Age and pneumonia were independently associated with the risk of death. CONCLUSIONS: SARS-CoV-2 infection already affects a significant number of Spanish patients on RRT, mainly those on ICH, hospitalization rates are very high and mortality is high; age and the development of pneumonia are factors associated with mortality.

Seasonal variations and influence of the weather on the appearance of peritoneal infection.

INTRODUCTION: Peritoneal infections are a common complication in patients undergoing peritoneal dialysis (PD) and are frequently the cause of the failure of the technique. Knowing the factors that can lead to their appearance helps to establish preventative measures. AIM: To understand the influence of climatic variables in the appearance of peritonitis, such as seasonal variation, the temperature and humidity in Asturias. METHOD: A retrospective, observational study of all peritoneal infections that occurred in our PD department over a period of 5 years (2007-2011). The region was divided lengthways into three areas: the coast, central area and mountains, each of which has a climatological season for reference, which is defined by the State Meteorology Agency (AEMET) (in Gijón, Oviedo and Mieres, respectively). The AEMET provided us with data on the humidity and average temperature of the months in which all the cases of peritonitis appeared. RESULTS: There were 171 cases of peritonitis (0.498 episodes/patient/year) in 201 patients (58±16 years, 59% males, 33% diabetics, 20±19 months on technique). We did not find any differences according to age, sex, having diabetes, nasal carrier status for Staphylococcus aureus or therapeutic modality. Overall, there were no differences among seasons. However, using spring as a reference (value 1), the incidence rate of gram-negative peritonitis (95% confidence interval) in summer, autumn and winter was 0.666 (0.211-1.832), 0.248 (0.000-0.912) and 0.292 (0.000-0.833), respectively (P<.001). We do not see this variation upon analysing the incidence rates of peritonitis caused by gram-positive bacteria. The average temperature of the days on which peritoneal infections were caused by gram-negative bacteria (15.46±3.71°C) was significantly higher than on those days when it was caused by gram-positive bacteria (13.61±3.89 °C) (P.022). There are no significant differences in relation to humidity (78.76 ± 4.40 vs. 77.5±3.69 %) (P.227). CONCLUSIONS: Overall, the rates of peritoneal infection are similar in all four seasons of the year, although in the case of gram-negative bacteria there is an increase in its incidence in spring and summer. The higher the temperature, the higher the risk that a peritoneal infection will be the result of a gram-negative bacterium.

[Results of the cooperative study of Spanish peritoneal dialysis registries: analysis of 12 years of follow-up]. / Resultados del trabajo cooperativo de los registros españoles de diálisis peritoneal: análisis de 12 años de seguimiento.

INTRODUCTION AND OBJECTIVES: There is currently no registry that gives a complete and overall view of the peritoneal dialysis (PD) situation in Spain. However, a report on PD in Spain was developed for various conferences and meetings over several years from data provided by each registry in the autonomous communities and regions. The main objective of this study is to analyse this data in aggregate and comparatively to obtain a representative sample of the Spanish population on PD in recent years, in order that analysis and results in terms of demographic data, penetration of the technique, geographical differences, incidence and prevalence, technical aspects, intermediate indicators, comorbidity, and outcomes such as patient and technique survival may be extrapolated to the whole country. DESIGN, MATERIAL AND METHOD: Observational cohort study of autonomous PD registries, covering the largest possible percentage of the adult Spanish population (over 14 years of age) on PD, at least in the last decade (1999-2010), and in the largest possible geographical area in which we were able to recruit. A precise data collection strategy was followed for each regional registry. Once the information was received and clarified, they were added as aggregate data for statistical study. RESULTS: The regional registries that participated represent a total geographical area that encompasses 32,853,251 inhabitants over 14 years of age, 84% of the total Spanish population older than that age. The mean annual rate of incidents per million inhabitants (ppm) was variable (between 17.81 ppm in Andalusia and 29.90 ppm in the Basque Country), with a discrete and permanent increase in the overall PD incidence in Spain being observed in recent years. The mean annual prevalence per million population (ppm) was very heterogeneous (from 42 to 99 ppm). A mean progressive increase in the use of automated peritoneal dialysis (APD) was observed. The peritonitis rate was approximately one episode every 25-30 months/patient, with a slight decrease being observed in recent years. The causes of discontinuing PD were distributed fairly evenly between communities; almost a third was due to patient death (mean 28%), a third was due to renal transplantation (mean 39%) and a third was due to transfer to haemodialysis (technique failure: mean 32%). The main comorbidities were cardiovascular disease (30.2%) and diabetes mellitus (24.2%). The overall accumulated mean survival was 92.2%, 82.8%, 74.2%, 64.8% and 57% after one, two, three, four and five years respectively. There was significantly and independently worse survival for older patients and those with cardiovascular disease, patients with diabetes mellitus, those on continuous ambulatory peritoneal dialysis (vs. APD), those who started PD before 2004 (analysed in Andalusia and Catalonia), and patients with lower residual renal function at the start of PD (analysed in the Levante registry). Similarly, the technique survival has improved, showing a mean figure above 50% after 5 years. CONCLUSIONS: The incidence and prevalence of PD in Spain are growing moderately and in a generalised manner and continue to maintain an irregular distribution by autonomous community. Both patient and technique survival were greater than 50% after 5 years, with an improvement being observed in recent years, and are comparable to countries with better results in this treatment.

Paricalcitol reduces proteinuria but does not modify peritoneal protein loss in patients on peritoneal dialysis.

INTRODUCTION: Paricalcitol, a selective activator of Vitamin D receptors, is successfully used as a treatment of hyperparathyroidism secondary to chronic kidney disease (CKD). In addition, it has been proposed for reducing proteinuria in patients with CKD. Nonetheless, little is known about its effect on peritoneal protein loss in patients on peritoneal dialysis (PD). OBJECTIVES: To analyse the efficiency of oral paricalcitol in secondary hyperparathyroidism control in PD patients and to verify its effect on urinary and peritoneal effluent protein loss. MATERIAL AND METHOD: Prospective study with a 12-month follow-up on a cohort of PD patients. Invention consisted of the introduction of paricalcitol for the treatment of secondary hyperparathyroidism. Paricalcitol was dosed according to parathyroid hormone (PTH): 1mg/day for patients with PTH < 500 pg/ml, and 2mg/day for those with higher PTH levels. Epidemiological, clinical and analytical data were analysed. RESULTS: 38 patients (56 ± 19 years, 55% women, 16% diabetics, technique time (14 ± 10 months) were included in the study. Thirty-three of them received 1mg/day of paricalcitol; the rest received 2mg/day. The use of paricalcitol was associated with a PTH decrease of 30.7 ± 6.8% (P<.001) after 12 months of treatment with no changes in calcium (8.82 ± 0.96 vs. 9.02 ± 0.91; P = .153) and phosphate levels (4.78 ± 0.63 vs. 4.93 ± 0.77; P = .693). Patients did not modify treatment concurrent with phosphate binders over the study period, nor did they change the cinacalcet dosage. However, fewer patients needed it by the end of the study. The PTH baseline levels were independent indicators of its decrease (b = 0.689, P = .018), and the rest of the analysed parameters were not affected. Over the study period there was a proteinuria decrease (0.79 ± 0.41 vs. 0.64 ± 0.36 g/day, P = .034) with no changes in renal function (7.2 ± 1.1 vs. 6.3 ± 0.9 ml/min, P =.104). Similarly, no differences were found in in the percentages of patients taking renin-angiotensin system inhibitors (71 vs. 68 %, P = .472) or the doses needed. There was no significant change in peritoneal protein loss (5.8 ± 1.9 vs. 6.0 ± 2.2g/24h, P = .731) nor in serum albumin levels (3.7 ± 1.1 vs. 3.7 ± 1.2g/dl, P = .697). CONCLUSIONS: The use of oral paricalcitol reduces PTH levels safely and substantially in patients on PD. Their use is associated with a proteinuria decrease and is not linked to a decrease of glomerular filtration rate or changes in the medication that could modify it. We have found no modification in the amount of peritoneal protein loss.