Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers

Study Overview
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Brief Summary
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This study will help to show the efficacy of vitamin D and address the optimal strategy to minimize renal injury in IgAN patients.

Official Title
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Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers

Conditions
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IgA Nephropathy

Intervention / Treatment
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* Drug: Calcitriol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy-proven Ig AN patients aged 20-70 years Patients with residual proteinuria > 500 mg/g creatinine despite renin-angiotensin system blockade and adequate blood pressure control for more than 3 months Patients who give informed consent, and 4) estimated GFR >= 30 ml/min/1.73 m2. Exclusion Criteria: patients < 20 years or > 70 years hypersensitivity to vitamin D analogs patients who need urgent dialysis hypercalcemia within 3 months (uncorrected serum calcium level > 10.2 mg/dL) clinical features of rapidly progressive glomerulonephritis life expectancy less than 24 months uncontrolled hypertension decompensated liver or lung disease symptomatic heart failure (NYHA class II-IV or LVEF < 40%) estimated GFR < 30 ml/min/1.73 m2.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral calcitriol<br>Calcio® | Drug: Calcitriol<br>* Calcitriol(1,25-dihydroxycholecalciferol, vitamin D3 analog)0.25 μg per day<br>|
| No Intervention: placebo<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in proteinuria | comparison of proteinuria amount checked by random urine protein/creatinine and 24hour urine protein | random urine protein/creatinine ratio every 2month and 24hour urine protein every 6month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in serum creatinine | comparison of renal function checked by serum creatinine and calculated renal function by MDRD equation | serum creatinine every 2month | 
| changes in systolic blood pressure and diastolic pressure | check systolic and diastolic blood pressure | check blood pressure at very first visit and every 2-month | 
| changes in urinary biomarkers (angiotensinogen, angiotensin II, TGF-beat, IL-6, MCP-1, TNF-alpha) | urine marker check every 6month | every 6month | 
| changes in serum 25(OH)2D3, 1,25(OH)2D3, parathyroid hormone | serum marker check every 6month | every 6month | 
| changes in serum inflammatory markers (hsCRP, IL-6) | serum marker check every 6month | every 6month |