- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00437463
Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor
November 17, 2010 updated by: Sanofi
Treatment of Early Immunoglobulin A Nephropathy by ACE Inhibitor - a Randomized Controlled Trial
To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hong Kong, Hong Kong
- Sanofi-Aventis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 2
|
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Experimental: 1
Ramipril
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2.5mg and increase to 5mg if patient do not develop symptomatic hypotension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
From the beginning to the end of the study
|
Development of proteinuria
Time Frame: From the beginning to the end of the study
|
From the beginning to the end of the study
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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
|
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
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From the beginning to the end of the study
|
Adverse effects of treatment
Time Frame: From the beginning to the end of the study
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From the beginning to the end of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Daniel Yuen, Sanofi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
February 20, 2007
First Submitted That Met QC Criteria
February 20, 2007
First Posted (Estimate)
February 21, 2007
Study Record Updates
Last Update Posted (Estimate)
November 18, 2010
Last Update Submitted That Met QC Criteria
November 17, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOE498_6015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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