ACEi/ARB Alone Versus ACEi/ARB Plus Steroids in the Treatment of Primary IgA Nephropathy, a RCT
Primary Purpose
Glomerulonephritis, IGA
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
prednisone + Inhibace/Cozaar
Inhibace/Cozaar
Sponsored by
About this trial
This is an interventional treatment trial for Glomerulonephritis, IGA
Eligibility Criteria
Inclusion Criteria:
- underwent renal biopsy within 1 year before start fo trial;
- 24 hour urinary protein excretion ranged between 1 to 7 g/d;
- eGFR, evaluated by MDRD formula, should be higher than 30 ml/min
Exclusion Criteria:
- crescentic glomerulonephritis;
- steroid therapy subjected within 1 year before trial;
- malignant hypertension(DBP> 130 mmHg and/or SBP> 220mmHg), resistant to anti-hypertensive agents;
- urinary protein excretion decrease below 1 g/l after run-in period;
- Myocardial infarction or cerebrovascular accident in 6 months preceding the trial;
- renovascular disease;
- diabetes mellitus;
- Malignancy, severe liver disease, refractory infection;
- peptic ulcer in active disease phase;
- pregnancy;
- other contraindication to the use of ACEi/ ARB or corticosteroid;
- alcohol abuse or drug addiction
Sites / Locations
Outcomes
Primary Outcome Measures
Serum creatinine
24 hour urinary protein excretion
Secondary Outcome Measures
Urinalysis
serum urea
serum albumin
Full Information
NCT ID
NCT00378443
First Posted
September 19, 2006
Last Updated
September 21, 2006
Sponsor
Peking University
1. Study Identification
Unique Protocol Identification Number
NCT00378443
Brief Title
ACEi/ARB Alone Versus ACEi/ARB Plus Steroids in the Treatment of Primary IgA Nephropathy, a RCT
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Peking University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glomerulonephritis, IGA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
prednisone + Inhibace/Cozaar
Intervention Type
Drug
Intervention Name(s)
Inhibace/Cozaar
Primary Outcome Measure Information:
Title
Serum creatinine
Title
24 hour urinary protein excretion
Secondary Outcome Measure Information:
Title
Urinalysis
Title
serum urea
Title
serum albumin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
underwent renal biopsy within 1 year before start fo trial;
24 hour urinary protein excretion ranged between 1 to 7 g/d;
eGFR, evaluated by MDRD formula, should be higher than 30 ml/min
Exclusion Criteria:
crescentic glomerulonephritis;
steroid therapy subjected within 1 year before trial;
malignant hypertension(DBP> 130 mmHg and/or SBP> 220mmHg), resistant to anti-hypertensive agents;
urinary protein excretion decrease below 1 g/l after run-in period;
Myocardial infarction or cerebrovascular accident in 6 months preceding the trial;
renovascular disease;
diabetes mellitus;
Malignancy, severe liver disease, refractory infection;
peptic ulcer in active disease phase;
pregnancy;
other contraindication to the use of ACEi/ ARB or corticosteroid;
alcohol abuse or drug addiction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Zhang, MD
Organizational Affiliation
Renal Division, Peking University First Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
18930568
Citation
Lv J, Zhang H, Chen Y, Li G, Jiang L, Singh AK, Wang H. Combination therapy of prednisone and ACE inhibitor versus ACE-inhibitor therapy alone in patients with IgA nephropathy: a randomized controlled trial. Am J Kidney Dis. 2009 Jan;53(1):26-32. doi: 10.1053/j.ajkd.2008.07.029. Epub 2008 Oct 19.
Results Reference
derived
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ACEi/ARB Alone Versus ACEi/ARB Plus Steroids in the Treatment of Primary IgA Nephropathy, a RCT
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