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

Yonsei University

Status: Completed

Conditions: IgA Nephropathy

Treatments: Drug: Calcitriol

Study type: Interventional

Funder types: Other

Identifiers

NCT01237028

4-2010-0439

Details and patient eligibility

About

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

Enrollment: 168 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 2 patient groups

oral calcitriol

Experimental group

Description:

Calcio®

Treatment:

Drug: Calcitriol

placebo

No Intervention group