Achievement of recommended treatment targets for bone and mineral metabolism in haemodialysis patients using paricalcitol: an observational study.

OBJECTIVE: Secondary hyperparathyroidism (SHPT) is a common problem among patients with chronic kidney disease (CKD) on haemodialysis. This study was conducted to assess the use, effectiveness and safety of intravenous paricalcitol in haemodialysis patients with various degrees of SHPT. MATERIAL AND METHODS: This observational, multicentre, prospective study was conducted in 14 Swedish dialysis centres from May 2007 to June 2008 and included 92 haemodialysis patients with a diagnosis of SHPT associated with CKD. The decision to initiate treatment with intravenous paricalcitol was made by the treating physician. No treatment algorithms were provided. RESULTS: Mean patient age was 64 years. Of the 92 patients included, 74 had an intact parathyroid hormone (iPTH) level of >300 pg/ml at baseline. Median iPTH was 584 pg/ml in patients with a baseline PTH of >300 pg/ml. During follow-up there was a decrease in iPTH to 323 pg/ml at 6 months (-45%, p < 0.0001). In parallel, there was a small increase in serum calcium, but serum phosphorus and the calcium × phosphorus product remained unchanged. CONCLUSIONS: This study showed that intravenous paricalcitol substantially and safely decreased iPTH in haemodialysis patients with a baseline iPTH above the Kidney Disease Outcomes Quality Initiative recommended target range (150-300 pg/ml) and had minimal impact on serum minerals.

Iron isomaltoside 1000: a new intravenous iron for treating iron deficiency in chronic kidney disease.

BACKGROUND: Patients with chronic kidney disease (CKD) often suffer from iron deficiency anemia necessitating treatment with intravenous iron. This study was designed to assess the safety of iron isomaltoside 1000 (Monofer) in CKD patients. The secondary objective was to assess its effect on iron deficiency anemia. METHODS: This open-label, noncomparative, multicenter trial assigned 182 patients with CKD (n=161 in dialysis and n=21 in predialysis) to iron isomaltoside 1000 either as 4 intravenous bolus injections of 100-200 mg iron per dose or as a fast high-dose infusion at baseline. Patients were generally undergoing erythropoiesis-stimulating agent (ESA) treatment (82%), and the dosage was to be kept constant during the trial. They were either switched from an existing parenteral maintenance therapy (n=144) or were not currently being treated with parenteral iron (n=38). Frequency of adverse events (AEs) and changes in markers of iron deficiency anemia were measured during 8 weeks from baseline. RESULTS: Nineteen treatment-related AEs occurred in 13 patients (7.1%) and after 584 treatments (3.3%). No anaphylactic or delayed allergic reactions were observed. There were no clinically significant changes in routine clinical laboratory tests or vital signs. Hemoglobin increased from 99.2 g/L (SD=9.0) at baseline to 111.2 g/L (SD=14.7) at week 8 in patients not currently treated with parenteral iron (p<0.001) and increased slightly or stabilized in patients in maintenance therapy. S-Ferritin, s-iron and transferrin saturation increased significantly at all visits. CONCLUSIONS: Iron isomaltoside 1000 was clinically well tolerated, safe and effective. This new intravenous iron may offer a further valuable choice in treating the anemia of CKD.

Itchy skin--a clinical problem for haemodialysis patients.

BACKGROUND: Uraemic pruritus affects many patients receiving chronic dialysis therapy for end-stage renal disease. It is a distressing symptom which has a negative impact on quality of life (QoL) of the patients. The condition is also very frustrating for both patients and physicians since no effective treatment for relief of the itch has been demonstrated. The pathophysiological mechanisms of pruritus are mainly unknown despite several hypotheses presented. Recent concepts refer to changes in the opioidergic system and derangements of the immune system. METHODS: In the Dialysis Outcomes and Practice Pattern Study (DOPPS I, 1996-2001) pruritus was assessed by a self-reported questionnaire. The relationship of pruritus to morbidity, mortality, QoL, sleep quality and patient biochemical laboratory data was studied in >200 randomly selected haemodialysis (HD) facilities in seven countries. Pruritus data were collected from >6000 HD patients. Analyses were adjusted for age, gender, race, Kt/V, haemoglobin, serum albumin, serum calcium, serum phosphorus, 13 comorbidities, depression, years on dialysis, country and facility clustering effects. RESULTS: Moderate-to-extreme itch was observed in 46% of prevalent HD patients. Differences in pruritus prevalence were found between countries (ranging from 38% in France to 55% in Italy) and facilities (5-75%). Pruritus was more common in patients on HD >3 months than in patients starting HD. A number of patients' serum characteristics, including high calcium, phosphorous and calcium x phosphorous product levels, were significantly associated with pruritus. Patients with moderate-to-severe pruritus were more likely to feel washed out and to have poor sleep quality, physician-diagnosed depression and a reduced QoL than patients with no or mild pruritus. A significant 15% higher mortality risk was observed in pruritic HD patients but this significance was not seen after adjusting the data for sleep quality measures. CONCLUSIONS: The self-reported prevalence of pruritus in HD patients is relatively high, 40-50%. Pruritus is associated with poor outcomes and a higher mortality risk, probably attributed to poor sleep quality. Better therapeutic treatments are needed for relief of distressing uraemic itching in HD patients.