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Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT01225445
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
102
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial
Study Start Date :
Apr 1, 2002
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Oct 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

ramipril 2.5 mg daily

Drug: Ramipril
2.5 mg daily
No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. blood pressure [5 years]

  2. proteinuria [5 years]

    over 1 g/day

  3. serum creatinine [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Medicine & Therapeutics, Prince of Wales Hospital Shatin Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

  • Principal Investigator: Cheuk Chun Szeto, MD, Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01225445
Other Study ID Numbers:
  • HOE 498/6015
First Posted:
Oct 21, 2010
Last Update Posted:
Oct 21, 2010
Last Verified:
Apr 1, 2002
Additional relevant MeSH terms:
Kidney Diseases
Proteinuria
Glomerulonephritis, IGA
Ramipril

Study Results

No Results Posted as of Oct 21, 2010