Official Title: “Treatment of Early Immunoglobulin A Nephropathy by ACE Inhibitor - a Randomized Controlled Trial”

To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: August 2011

Intervention(s) in this Clinical Trial

• Drug: Ramipril
  • 2.5mg and increase to 5mg if patient do not develop symptomatic hypotension

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Ramipril
• No Intervention: 2

Primary Measures

• Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy)
  • Time Frame: From the beginning to the end of the study
    Safety Issue?: No
• Development of proteinuria
  • Time Frame: From the beginning to the end of the study
    Safety Issue?: No
• 20% decline in creatinine clearance, as determined by 24-hour urine collection or estimated by the Gault-Cockroft equation
  • Time Frame: From the beginning to the end of the study
    Safety Issue?: No
• body weight, blood pressure, pulse
  • Time Frame: From the beginning to the end of the study
    Safety Issue?: No
• Adverse effects of treatment
  • Time Frame: From the beginning to the end of the study
    Safety Issue?: Yes

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Daniel Yuen Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00437463

Study ID Number: HOE498_6015

ClinicalTrials.gov Identifier: NCT00437463

Health Authority: Hong Kong: Department of Health