IgA Nephropathy
Conditions
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.
Interventions
DRUGCalcitriol
Calcitriol(1,25-dihydroxycholecalciferol, vitamin D3 analog)0.25 μg per day
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 urinary biomarkers (angiotensinogen, angiotensin II, TGF-beat, IL-6, MCP-1, TNF-alpha) | every 6month | urine marker check every 6month |
| 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 |
Countries
South Korea
Outcome results
None listed