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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01225445
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : October 21, 2010
Information provided by:
Chinese University of Hong Kong

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Biopsy-confirmed IgA Nephropathy Proteinuria Less Than 0.5 g Per Day Normal Blood Pressure Serum Creatinine Below 120 Umol/l Drug: Ramipril Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial
Study Start Date : April 2002
Actual Primary Completion Date : June 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Ramipril

Arm Intervention/treatment
Experimental: Treatment
ramipril 2.5 mg daily
Drug: Ramipril
2.5 mg daily

No Intervention: Control

Primary Outcome Measures :
  1. blood pressure [ Time Frame: 5 years ]
  2. proteinuria [ Time Frame: 5 years ]
    over 1 g/day

  3. serum creatinine [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01225445

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Hong Kong
Department of Medicine & Therapeutics, Prince of Wales Hospital
Shatin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
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Principal Investigator: Cheuk Chun Szeto, MD Chinese University of Hong Kong
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Responsible Party: Cheuk Chun Szeto, The Chinese University of Hong Kong Identifier: NCT01225445    
Other Study ID Numbers: HOE 498/6015
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: October 21, 2010
Last Verified: April 2002
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Urination Disorders
Urological Manifestations
Autoimmune Diseases
Immune System Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents