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

October 20, 2010 updated by: Chinese University of Hong Kong
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

  • Hong Kong
      • Shatin, Hong Kong
        • Department of Medicine & Therapeutics, Prince of Wales Hospital

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 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Treatment
ramipril 2.5 mg daily
Drug: Ramipril
2.5 mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure
Time Frame: 5 years
5 years
proteinuria
Time Frame: 5 years
over 1 g/day
5 years
serum creatinine
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

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

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

April 1, 2002

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

October 20, 2010

First Submitted That Met QC Criteria

October 20, 2010

First Posted (Estimate)

October 21, 2010

Study Record Updates

Last Update Posted (Estimate)

October 21, 2010

Last Update Submitted That Met QC Criteria

October 20, 2010

Last Verified

April 1, 2002

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOE 498/6015

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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