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Completed

NCT Number: NCT00437463

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

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

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Key information

Conditions

Glomerulonephritis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ramipril

Drug

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

Primary outcomes

  1. Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy)

    Time frame: From the beginning to the end of the study

  2. Development of proteinuria

    Time frame: From the beginning to the end of the study

  3. 20% decline in creatinine clearance, as determined by 24-hour urine collection or estimated by the Gault-Cockroft equation

    Time frame: From the beginning to the end of the study

  4. body weight, blood pressure, pulse

    Time frame: From the beginning to the end of the study

  5. Adverse effects of treatment

    Time frame: From the beginning to the end of the study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Treatment of Early Immunoglobulin A Nephropathy by ACE Inhibitor - a Randomized Controlled Trial

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Feb 21, 2007
Registry last updated
Nov 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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