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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00437463
First Posted: February 21, 2007
Last Update Posted: November 18, 2010
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.
Information provided by:
Sanofi
  Purpose
To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.

Condition Intervention Phase
Glomerulonephritis Drug: Ramipril Phase 3

Study Type: Interventional
Study Design: 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

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 ]
  • Development of proteinuria [ Time Frame: From the beginning to the end of the study ]
  • 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 ]
  • body weight, blood pressure, pulse [ Time Frame: From the beginning to the end of the study ]
  • Adverse effects of treatment [ Time Frame: From the beginning to the end of the study ]

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
Ramipril
Drug: Ramipril
2.5mg and increase to 5mg if patient do not develop symptomatic hypotension
No Intervention: 2

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00437463


Locations
Hong Kong
Sanofi-Aventis
Hong Kong, Hong Kong
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Daniel Yuen Sanofi
  More Information

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00437463     History of Changes
Other Study ID Numbers: HOE498_6015
First Submitted: February 20, 2007
First Posted: February 21, 2007
Last Update Posted: November 18, 2010
Last Verified: November 2010

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