Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor
Treatment of Early Immunoglobulin A Nephropathy by ACE Inhibitor - a Randomized Controlled Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2004
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 20, 2007
CompletedFirst Posted
Study publicly available on registry
February 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedNovember 18, 2010
November 1, 2010
6.2 years
February 20, 2007
November 17, 2010
Conditions
Outcome Measures
Primary Outcomes (5)
Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy)
From the beginning to the end of the study
Development of proteinuria
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
From the beginning to the end of the study
body weight, blood pressure, pulse
From the beginning to the end of the study
Adverse effects of treatment
From the beginning to the end of the study
Study Arms (2)
1
EXPERIMENTALRamipril
2
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- biopsy-confirmed IgA nephropathy
- proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 µmol/l
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis
Hong Kong, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Daniel Yuen
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 20, 2007
First Posted
February 21, 2007
Study Start
July 1, 2004
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
November 18, 2010
Record last verified: 2010-11