Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

Study Overview
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Brief Summary
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The safety and efficacy of Caltriol on mild proteinuria (<1.0g/d) reduction in CKD patients.

Detailed Description
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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.

Official Title
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Phase 4 Study of Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

Conditions
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Chronic Kidney Disease, Proteinuria

Intervention / Treatment
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* Drug: Calcitriol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18-75 years clinical diagnosed and/or biopsy-confirmed primary glomerulonephritis proteinuria 0.15-1.0 g/d in 2 consecutive samples within 4 weeks despite ACE inhibitor (ACEI) or angiotensin receptor blocker (ARB) treatment for at least 1 year or ACEI/ARB withdrawal because of of drug intolerances (low blood pressure, cough, hyperkalemia) for at least 1 month estimated glomerular filtration rate (eGFR)>60ml/min/1/73m2 corticosteroid and immunosuppressive agents withdrawal for at least 6 months normal blood pressure serum intact parathyroid hormone (iPTH) level >20pg/mL corrected serum calcium level < or = 2.55 mmol/L serum phosphorus level < or = 1.68 mmol/L 24 hours urinary calcium excretion level < or = 7.5 mmol not receive treatment of vitamin D or its analogue within 6 months willigness to give written consent and comply with the study protocol Exclusion Criteria: history of sensitivity or allergy to calcitriol or other vitamin D analogs pregnancy, lactating women history of severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension history of malignancy history of extraskeletal calcification, hyperuricemia, gout, kidney stone, gall stone, bone diseases patients receiving drugs contains of calcium patients receiving cimetidine, trimethoprim, or other drugs which can increase tubular creatinine reabsorption participation in any other trials within 1 month history of non-compliance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcitriol<br>General treatments (such as blood pressure control, lipid lowering, and so on) plus Calcitriol 0.5 ug/BIW for 24 weeks. | Drug: Calcitriol<br>* Calcitriol 0.5 ug/BIW for 24 weeks.<br>* Other names: 1, 25 - dihydroxy Cholecalciferol;|
| No Intervention: Control<br>General treatments. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage change of proteinuia |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of patients achieving at least a 15% decrease in proteinuria |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild proteinuria, calcitriol, renal function, blood pressure