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Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor

NCT ID: NCT00437463

Last Updated: 2010-11-18

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

2004-07-31

Study Completion Date

2010-09-30

Brief Summary

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To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.

Detailed Description

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Conditions

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Glomerulonephritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Ramipril

Group Type EXPERIMENTAL

Ramipril

Intervention Type DRUG

2.5mg and increase to 5mg if patient do not develop symptomatic hypotension

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ramipril

2.5mg and increase to 5mg if patient do not develop symptomatic hypotension

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* biopsy-confirmed IgA nephropathy
* proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 µmol/l

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Daniel Yuen

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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HOE498_6015

Identifier Type: -

Identifier Source: org_study_id