ACEi/ARB Alone Versus ACEi/ARB Plus Steroids in the Treatment of Primary IgA Nephropathy, a RCT

Glomerulonephritis, IGA Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00378443
• Other study ID #: [2006]022
• Status: Active, not recruiting
• Phase: N/A
• First received: September 19, 2006
• Last updated: September 21, 2006
• Start date: January 2006
• Est. completion date: June 2007

Study information

• Verified date: September 2006
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis
• Glomerulonephritis, IGA

Intervention

Drug:
• prednisone + Inhibace/Cozaar

• Inhibace/Cozaar

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum creatinine
Primary	24 hour urinary protein excretion
Secondary	Urinalysis
Secondary	serum urea
Secondary	serum albumin