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NCT Number: NCT01225445

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

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.

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Key information

Conditions

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

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Medicine & Therapeutics, Prince of Wales Hospital

Shatin, Hong Kong

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ramipril

Drug

2.5 mg daily

Primary outcomes

  1. blood pressure

    Time frame: 5 years

  2. proteinuria

    Time frame: 5 years

    over 1 g/day

  3. serum creatinine

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Oct 21, 2010
Registry last updated
Oct 21, 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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