Back to resultsTreatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial
Primary Purpose
Biopsy-confirmed IgA Nephropathy, Proteinuria Less Than 0.5 g Per Day, Normal Blood Pressure
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 Biopsy-confirmed IgA Nephropathy
Eligibility Criteria
Inclusion Criteria:
- age between 18 and 65
- biopsy-confirmed IgA nephropathy
- proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 umol/l
- willingness to give written informed consent and willingness to participate in and comply with the study protocol
Exclusion Criteria:
- expected survival less than 2 years
- 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
- history of non-compliance to medical regimens and patients who are considered potentially unreliable
- known history of sensitivity / allergy to ACE inhibitor
Sites / Locations
- Department of Medicine & Therapeutics, Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
ramipril 2.5 mg daily
Outcomes
Primary Outcome Measures
blood pressure
proteinuria
over 1 g/day
serum creatinine
Secondary Outcome Measures
Full Information
NCT ID
NCT01225445
First Posted
October 20, 2010
Last Updated
October 20, 2010
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01225445
Brief Title
Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial
Official Title
Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2002
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in the world. The treatment of IgA nephropathy with normal renal function and minimal proteinuria is unknown. Since angiotensin-converting enzyme (ACE) inhibitors reduce proteinuria and retard the rate of decline of renal function in chronic proteinuric nephropathies, including IgA nephropathy. The investigators conduct a randomized control study to evaluate the efficacy of ACE inhibitor in the treatment of early IgA nephropathy. Sixty patients with biopsy-proven IgA nephropathy and minimal proteinuria are recruited. They will be randomized to ramipril for 5 years or no treatment. Blood pressure, proteinuria and renal function will be monitored. This study will explore the effects of ACE inhibitor in the treatment of early IgA nephropathy, which is a major cause of dialysis-dependent renal failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biopsy-confirmed IgA Nephropathy, Proteinuria Less Than 0.5 g Per Day, Normal Blood Pressure, Serum Creatinine Below 120 Umol/l
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
ramipril 2.5 mg daily
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Ramipril
Intervention Description
2.5 mg daily
Primary Outcome Measure Information:
Title
blood pressure
Time Frame
5 years
Title
proteinuria
Description
over 1 g/day
Time Frame
5 years
Title
serum creatinine
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age between 18 and 65
biopsy-confirmed IgA nephropathy
proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 umol/l
willingness to give written informed consent and willingness to participate in and comply with the study protocol
Exclusion Criteria:
expected survival less than 2 years
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
history of non-compliance to medical regimens and patients who are considered potentially unreliable
known history of sensitivity / allergy to ACE inhibitor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheuk Chun Szeto, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine & Therapeutics, Prince of Wales Hospital
City
Shatin
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial
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