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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: February 20, 2007
Last updated: November 17, 2010
Last verified: November 2010

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

Condition Intervention Phase
Drug: Ramipril
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Early Immunoglobulin A Nephropathy by ACE Inhibitor - a Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome 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 ] [ Designated as safety issue: No ]
  • Development of proteinuria [ Time Frame: From the beginning to the end of the study ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • body weight, blood pressure, pulse [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Adverse effects of treatment [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: July 2004
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Ramipril
2.5mg and increase to 5mg if patient do not develop symptomatic hypotension
No Intervention: 2


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Please refer to this study by its identifier: NCT00437463

Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
Study Director: Daniel Yuen Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis Identifier: NCT00437463     History of Changes
Other Study ID Numbers: HOE498_6015
Study First Received: February 20, 2007
Last Updated: November 17, 2010
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Angiotensin-Converting Enzyme Inhibitors
Immunoglobulin A
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses processed this record on April 15, 2014