Status:
COMPLETED
Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor
Lead Sponsor:
Sanofi
Conditions:
Glomerulonephritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.
Eligibility Criteria
Inclusion
- biopsy-confirmed IgA nephropathy
- proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 µmol/l
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00437463
Start Date
July 1 2004
End Date
September 1 2010
Last Update
November 18 2010
Active Locations (1)
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1
Sanofi-Aventis
Hong Kong, Hong Kong