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Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor

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Disease Information

Descriptive Information
Brief Title † Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor
Official Title † Treatment of Early Immunoglobulin A Nephropathy by ACE Inhibitor - a Randomized Controlled Trial
Brief Summary To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.
Detailed Description
Study Phase Phase 3
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy)
Secondary Outcome Measure †
Condition † Glomerulonephritis
Intervention † DrugRamipril
Study Arms / Comparison Groups 1 Ramipril 2
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 60
Start Date † July 2004
Completion Date September 2010
Primary Completion Date September 2010
Eligibility 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.
Gender Both
Ages 18 Years - 65 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Hong Kong
Administrative Information
NCT ID † NCT00437463
Organization ID HOE498_6015
Secondary IDs ††
Responsible Party
Study Sponsor † Sanofi
Collaborators ††
Investigators † Study Director: Daniel Yuen, Sanofi
Information Provided By
Verification Date November 2010
First Received Date † February 20, 2007
Last Updated Date November 17, 2010
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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