ACEi/ARB Alone Versus ACEi/ARB Plus Steroids in the Treatment of Primary IgA Nephropathy, a RCT
Information source: Peking University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glomerulonephritis, IGA
Intervention: prednisone + Inhibace/Cozaar (Drug); Inhibace/Cozaar (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Peking University Official(s) and/or principal investigator(s):
Hong Zhang, MD, Principal Investigator, Affiliation: Renal Division, Peking University First Hospital
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.
Clinical Details
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Serum creatinine24 hour urinary protein excretion
Secondary outcome: Urinalysisserum urea serum albumin
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.
Eligibility
Minimum age: 16 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: January 2006
Ending date: June 2007
Last updated: September 21, 2006
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