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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00437463
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : November 18, 2010
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Brief Summary:
To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.

Condition or disease Intervention/treatment Phase
Glomerulonephritis Drug: Ramipril Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Early Immunoglobulin A Nephropathy by ACE Inhibitor - a Randomized Controlled Trial
Study Start Date : July 2004
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Ramipril
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: Ramipril
2.5mg and increase to 5mg if patient do not develop symptomatic hypotension
No Intervention: 2

Primary Outcome Measures :
  1. 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 ]
  2. Development of proteinuria [ Time Frame: From the beginning to the end of the study ]
  3. 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 ]
  4. body weight, blood pressure, pulse [ Time Frame: From the beginning to the end of the study ]
  5. Adverse effects of treatment [ Time Frame: From the beginning to the end of the study ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00437463

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

Responsible Party: Trial Transparency Team, sanofi-aventis Identifier: NCT00437463     History of Changes
Other Study ID Numbers: HOE498_6015
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: November 18, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Immunoglobulin A
Angiotensin-Converting Enzyme Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents