Glomerulonephritis, IGA
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGprednisone + Inhibace/Cozaar
DRUGInhibace/Cozaar
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum creatinine | — |
| 24 hour urinary protein excretion | — |
Secondary
| Measure | Time frame |
|---|---|
| Urinalysis | — |
| serum urea | — |
| serum albumin | — |
Outcome results
None listed