NCT01512862

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

Additive Renoprotective Effects of Oral Calcitriol in Nondiabetic Chronic Kidney Disease Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Proteinuria

Interventions

Type	Name	Description
DRUG	Calcitriol	Dosage of 0.25 mcg administered orally once daily for 6 weeks and dose escalated to 0.5 mcg orally once daily up to 6 months
DRUG	Placebo	Dosage of 0.25 mcg administered orally once daily for 6 weeks and dose escalated to 0.5 mcg orally once daily up to 6 months

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-12-01
• Completion: 2013-12-01
• First posted: 2012-01-19
• Last updated: 2012-04-10

Locations

3 sites across 1 country: South Korea