Back to resultsTreatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor
Primary Purpose
Glomerulonephritis
Status
Completed
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Ramipril
Sponsored by
About this trial
This is an interventional treatment trial for Glomerulonephritis
Eligibility 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.
Sites / Locations
- Sanofi-Aventis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Ramipril
Outcomes
Primary Outcome Measures
Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy)
Development of proteinuria
20% decline in creatinine clearance, as determined by 24-hour urine collection or estimated by the Gault-Cockroft equation
body weight, blood pressure, pulse
Adverse effects of treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00437463
Brief Title
Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor
Official Title
Treatment of Early Immunoglobulin A Nephropathy by ACE Inhibitor - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glomerulonephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Ramipril
Arm Title
2
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Ramipril
Intervention Description
2.5mg and increase to 5mg if patient do not develop symptomatic hypotension
Primary Outcome Measure Information:
Title
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
Title
Development of proteinuria
Time Frame
From the beginning to the end of the study
Title
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
Title
body weight, blood pressure, pulse
Time Frame
From the beginning to the end of the study
Title
Adverse effects of treatment
Time Frame
From the beginning to the end of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Yuen
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor
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