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

NCT ID: NCT01225445

Last Updated: 2010-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Biopsy-confirmed IgA Nephropathy Proteinuria Less Than 0.5 g Per Day Normal Blood Pressure Serum Creatinine Below 120 Umol/l

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

ramipril 2.5 mg daily

Group Type EXPERIMENTAL

Ramipril

Intervention Type DRUG

2.5 mg daily

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ramipril

2.5 mg daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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The Chinese University of Hong Kong

Principal Investigators

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Cheuk Chun Szeto, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Department of Medicine & Therapeutics, Prince of Wales Hospital

Shatin, , Hong Kong

Site Status

Countries

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Hong Kong

References

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Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

Reference Type DERIVED
PMID: 38299639 (View on PubMed)

Other Identifiers

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HOE 498/6015

Identifier Type: -

Identifier Source: org_study_id