Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glomerulonephritis
Intervention: Ramipril (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Daniel Yuen, Study Director, Affiliation: Sanofi-Aventis
Summary
To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA
nephropathy.
Clinical Details
Official title: Treatment of Early Immunoglobulin A Nephropathy by ACE Inhibitor - a Randomized Controlled Trial
Study design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy)Development of proteinuria 20% decline in creatinine clearance, as determined by 24-hour urine collection or estimated by the Gault-Cockroft equation body weight, blood pressure, pulse Adverse effects of treatment
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Sanofi-Aventis, Hong Kong, Hong Kong
Additional Information
Starting date: July 2004
Last updated: May 22, 2008
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