Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD
The safety and efficacy of Caltriol on mild proteinuria (<1.0g/d) reduction in CKD patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 4 Study of Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD|
- the percentage change of proteinuia [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- the proportion of patients achieving at least a 15% decrease in proteinuria [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- mean change of renal function (serum creatine, cystatin C, eGFR) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- blood pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
General treatments (such as blood pressure control, lipid lowering, and so on) plus Calcitriol 0.5 ug/BIW for 24 weeks.
Calcitriol 0.5 ug/BIW for 24 weeks.
Other Name: 1, 25 - dihydroxy Cholecalciferol
No Intervention: Control
Proteinuria is not only a capital sign of kidney disease, but also a marker of chronic kidney disease (CKD) progression. Emerging evidence in patients with CKD show that vitamin D and its analogs can reduce proteinuria or albuminuria in the presence of angiotensin-converting enzyme inhibithion. While some of the studies reported that vitamin D receptor activation has been associated with increased serum creatinine and reduced estimated glomerular filtration rates. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy and safety of Calcitriol in the treatment of mild proteinuria (<1.0g/d) CKD patients,which has no specific treatment at present.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01820832
|Contact: Jing Chen, M.D. PhDfirstname.lastname@example.org|
|Contact: Li You, M.D. PhDemail@example.com|
|Huashan Hospital, Fudan University||Not yet recruiting|
|Shanghai, Shanghai, China, 200040|
|Contact: Li You, M.D. PhD 86-21-52888133 firstname.lastname@example.org|
|Principal Investigator:||Jing Chen, M.D. PhD||Division of Nephrology, Huashan Hospital, Fudan University|