Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor
- Registration Number
- NCT00437463
- Lead Sponsor
- Sanofi
- Brief Summary
To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- biopsy-confirmed IgA nephropathy
- proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 µmol/l
Exclusion Criteria
- pregnant or nursing mother, or women of childbearing potential without an effective method of birth control
- history of myocardial infarction, congestive heart failure, or any other medical indication that necessitate the use of ACE inhibitor
- evidence of clinically significant hepatic, gastrointestinal, autoimmune disease
- history of malignancy, drug or alcohol abuse
- participation in any previous trial on ACE inhibitor
- taking other investigational drugs within the past 30 days
- known history of sensitivity / allergy to ACE inhibitor
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Ramipril Ramipril
- Primary Outcome Measures
Name Time Method Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy) From the beginning to the end of the study Development of proteinuria From the beginning to the end of the study 20% decline in creatinine clearance, as determined by 24-hour urine collection or estimated by the Gault-Cockroft equation From the beginning to the end of the study body weight, blood pressure, pulse From the beginning to the end of the study Adverse effects of treatment From the beginning to the end of the study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanofi-Aventis
🇭🇰Hong Kong, Hong Kong