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

Not Applicable

Completed

• Conditions: IgA Nephropathy
• Interventions: Drug: Calcitriol

• Registration Number: NCT01237028
• Lead Sponsor: Yonsei University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Study Start: 2011-03
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-05
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral calcitriol	Calcitriol	Calcio®

Primary Outcome Measures

Name	Time	Method
changes in proteinuria	random urine protein/creatinine ratio every 2month and 24hour urine protein every 6month	comparison of proteinuria amount checked by random urine protein/creatinine and 24hour urine protein

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

National Health Insurance Corporation Ilsan Hospital; 🇰🇷 Goyang, Korea, Republic of

CHA University Bundang Medical Center; 🇰🇷 Seongnam, Korea, Republic of

Wongkwang University Sanbon Medical Center; 🇰🇷 Gunpo, Korea, Republic of

Kwandong University Myongji Hospital; 🇰🇷 Goyang, Korea, Republic of

Ewha Womans University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of