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

Glomerulonephritis Clinical Trial

Official title:

Treatment of Early Immunoglobulin A Nephropathy by ACE Inhibitor - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437463
• Other study ID #: HOE498_6015
• Status: Completed
• Phase: Phase 3
• First received: February 20, 2007
• Last updated: November 17, 2010
• Start date: July 2004
• Est. completion date: September 2010

Study information

• Verified date: November 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Sanofi-Aventis	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Development of proteinuria		From the beginning to the end of the study	No
Primary	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	No
Primary	body weight, blood pressure, pulse		From the beginning to the end of the study	No
Primary	Adverse effects of treatment		From the beginning to the end of the study	Yes