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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Glomerulonephritis

Treatments: Drug: Ramipril

Study type: Interventional

Funder types: Industry

Identifiers

NCT00437463

HOE498_6015

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1

Experimental group

Description:

Ramipril

Treatment:

Drug: Ramipril

2

No Intervention group