drugset / Trial / NCT01512862

Anti-proteinuric Effect of Calcitriol in Non-diabetic Kidney Disease Patients

NCT01512862

Phase 4 Unknown 240 enrolled Seoul National University Hospital
RandomizedParallel-groupDouble-blindTreatment

Summary

Proteinuria is not only a marker of chronic kidney disease (CKD) progression, but also a marker of cardiovascular disease and death. In previous studies, active vitamin D deficiency is associated with cardiovascular risk factors such as albuminuria, diabetes mellitus, and lower glomerular filtration rate (GFR). And calcitriol was shown to have a preventive effect in progressive glomerular damage in a renal ablation model. Calcitriol, an active form of vitamin D (1,25-dihydroxyvitamin-D3), is commonly used for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney diseases. Therefore, the objective of this study is to evaluate the anti-proteinuric effect of calcitriol in non-diabetic kidney disease patients. They will be treated with calcitriol and placebo for 24 weeks and observed for 24 weeks after treatment. Proteinuria, renal function, serum and urinary inflammatory markers, and adverse event will be monitored.

Timeline

Start
2012-01
Primary completion
2012-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Calcitriol Small molecule 0.5 ug Oral

Indications