Overview

This trial is active, not recruiting.

Condition glomerulonephritis, iga
Treatments prednisone + inhibace/cozaar, inhibace/cozaar
Sponsor Peking University
Start date January 2006
End date June 2007
Trial identifier NCT00378443, [2006]022

Summary

IgA nephropathy( IgAN) is the most common primary glomerulonephritis worldwide. Since the etiology of the disease is not clearly understood, no specific therapeutic strategies was defined for IgAN. Both ACEi/ARB and steroid was found to be effective in slowing the rate of disease progression, but the use of steroid was restricted because of its side effects. However, there is no evidence from RCT on the question of whether combined use of steroid with ACEi/ARB can bring more benefit to IgAN patients than ACEi/ARB alone. We therefore undertook a randomized, multicenter study to investigate the efficacy and safety profile of combined use of ACEi/ARB plus steroid compared with ACEi/ARB alone in the treatment of patients with IgAN.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Serum creatinine
time frame:
24 hour urinary protein excretion
time frame:

Secondary Outcomes

Measure
Urinalysis
time frame:
serum urea
time frame:
serum albumin
time frame:

Eligibility Criteria

Male or female participants from 16 years up to 65 years old.

Inclusion Criteria: 1. underwent renal biopsy within 1 year before start fo trial; 2. 24 hour urinary protein excretion ranged between 1 to 7 g/d; 3. eGFR, evaluated by MDRD formula, should be higher than 30 ml/min Exclusion Criteria: 1. crescentic glomerulonephritis; 2. steroid therapy subjected within 1 year before trial; 3. malignant hypertension(DBP> 130 mmHg and/or SBP> 220mmHg), resistant to anti-hypertensive agents; 4. urinary protein excretion decrease below 1 g/l after run-in period; 5. Myocardial infarction or cerebrovascular accident in 6 months preceding the trial; 6. renovascular disease; 7. diabetes mellitus; 8. Malignancy, severe liver disease, refractory infection; 9. peptic ulcer in active disease phase; 10. pregnancy; 11. other contraindication to the use of ACEi/ ARB or corticosteroid; 12. alcohol abuse or drug addiction

Additional Information

Principal investigator Hong Zhang, MD
Description IgA nephropathy( IgAN) is the most common primary glomerulonephritis worldwide. Since the etiology of the disease is not clearly understood, no specific therapeutic strategies was defined for IgAN. In the many studies on the treatment of IgAN, both ACEi/ARB and steroid was found to be effective in slowing the rate of disease progression, but the use of steroid was restricted because of its side effects, and ACEi/ARB was considered to be the first line therapy. However, there is no evidence from RCT on the question of whether combined use of steroid with ACEi/ARB can bring more benefit to IgAN patients than ACEi/ARB alone. We therefore undertook a randomized, multicenter study to investigate the efficacy and safety profile of combined use of ACEi/ARB plus steroid compared with ACEi/ARB alone in the treatment of patients with IgAN.
Trial information was received from ClinicalTrials.gov and was last updated in September 2006.
Information provided to ClinicalTrials.gov by Peking University.