Nonskeletal and skeletal effects of high doses versus low doses of vitamin D3 in renal transplant recipients: Results of the VITALE (VITamin D supplementation in renAL transplant recipients) study, a randomized clinical trial.

Vitamin D sufficiency is associated with a reduced risk of fractures, diabetes mellitus, cardiovascular events, and cancers, which are frequent complications after renal transplantation. The VITALE (VITamin D supplementation in renAL transplant recipients) study is a multicenter double-blind randomized trial, including nondiabetic adult renal transplant recipients with serum 25-hydroxy vitamin D (25(OH) vitamin D) levels of <30 ng/mL, which is randomized 12 to 48 months after transplantation to receive high (100 000 IU) or low doses (12 000 IU) of cholecalciferol every 2 weeks for 2 months and then monthly for 22 months. The primary outcome was a composite endpoint, including diabetes mellitus, major cardiovascular events, cancer, and death. Of 536 inclusions (50.8 [13.7] years, 335 men), 269 and 267 inclusions were in the high-dose and low-dose groups, respectively. The serum 25(OH) vitamin D levels increased by 23 versus 6 ng/mL in the high-dose and low-dose groups, respectively (P < .0001). In the intent-to-treat analysis, 15% versus 16% of the patients in the high-dose and low-dose groups, respectively, experienced a first event of the composite endpoint (hazard ratio, 0.94 [0.60-1.48]; P = .78), whereas 1% and 4% of patients in the high-dose and low-dose groups, respectively, experienced an incident symptomatic fracture (odds ratio, 0.24 [0.07-0.86], P = .03). The incidence of adverse events was similar between the groups. After renal transplantation, high doses of cholecalciferol are safe but do not reduce extraskeletal complications (trial registration: ClinicalTrials.gov; identifier: NCT01431430).

[Prevalence of iron deficiency in patients with non-dialysis chronic kidney disease: The CARENFER national, multicentre, observational study]. / Prévalence de la carence martiale dans une population de patients insuffisants rénaux chroniques non dialysés : étude nationale multicentrique observationnelle CARENFER.

INTRODUCTION: Iron deficiency is common and associated with worse outcomes in patients with non-dialysis chronic kidney disease. We performed a national, multicentre, observational and transversal study to assess the prevalence of iron deficiency as well as current iron deficiency screening practices in this population. PATIENTS AND METHODS: A total of 25 nephrology centres in France participated in the study. All adult non-dialysis chronic kidney disease patients who met the inclusion (GFR>15mL/min/1.73m2) and exclusion criteria and provided consent were systematically recruited over a 4-week inclusion period. Investigators were asked to perform a blood test (hemoglobin concentration, serum iron, serum ferritin and transferrin saturation) and to complete a questionnaire about their iron status monitoring practices. The primary objective was to assess the prevalence of iron deficiency (serum ferritin<100µg/L and/or transferrin saturation<20%). Secondary objectives were to evaluate the prevalence of absolute iron deficiency (serum ferritin<100µg/L and transferrin saturation<20%) and functional iron deficiency (serum ferritin≥100µg/L and transferrin saturation<20%), the prevalence of iron deficiency according to haemoglobin concentration and chronic kidney disease stage, the proportion of centres that perform routine evaluation of iron status and the number of patients receiving iron supplementation. RESULTS: A total of 1211 patients with non-dialysis chronic kidney disease were included in the analysis. The overall prevalence of iron deficiency was 47.1%. The rates of absolute iron deficiency and functional iron deficiency and anaemia were 13.4% and 17.1%, respectively. Among the 25 participating centres, 12 reported routine assessment of iron status in non-dialysis chronic kidney disease patients. CONCLUSION: In this observational study, a high prevalence of iron deficiency was observed among non-dialysis chronic kidney disease patients. Less than half of participating centres reported routine assessment of iron status.

Recommendations for the use of tolvaptan in autosomal dominant polycystic kidney disease: a position statement on behalf of the ERA-EDTA Working Groups on Inherited Kidney Disorders and European Renal Best Practice.

Recently, the European Medicines Agency approved the use of the vasopressin V2 receptor antagonist tolvaptan to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adult patients with chronic kidney disease stages 1-3 at initiation of treatment with evidence of rapidly progressing disease. In this paper, on behalf of the ERA-EDTA Working Groups of Inherited Kidney Disorders and European Renal Best Practice, we aim to provide guidance for making the decision as to which ADPKD patients to treat with tolvaptan. The present position statement includes a series of recommendations resulting in a hierarchical decision algorithm that encompasses a sequence of risk-factor assessments in a descending order of reliability. By examining the best-validated markers first, we aim to identify ADPKD patients who have documented rapid disease progression or are likely to have rapid disease progression. We believe that this procedure offers the best opportunity to select patients who are most likely to benefit from tolvaptan, thus improving the benefit-to-risk ratio and cost-effectiveness of this treatment. It is important to emphasize that the decision to initiate treatment requires the consideration of many factors besides eligibility, such as contraindications, potential adverse events, as well as patient motivation and lifestyle factors, and requires shared decision-making with the patient.