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

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01225445
First received: October 20, 2010
Last updated: NA
Last verified: April 2002
History: No changes posted
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • blood pressure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • proteinuria [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    over 1 g/day

  • serum creatinine [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2002
Study Completion Date: October 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
ramipril 2.5 mg daily
Drug: Ramipril
2.5 mg daily
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225445

Locations
Hong Kong
Department of Medicine & Therapeutics, Prince of Wales Hospital
Shatin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Cheuk Chun Szeto, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Cheuk Chun Szeto, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01225445     History of Changes
Other Study ID Numbers: HOE 498/6015
Study First Received: October 20, 2010
Last Updated: October 20, 2010
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Proteinuria
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Angiotensin-Converting Enzyme Inhibitors
Ramipril
Enzyme Inhibitors
Immunoglobulin A
Immunoglobulins
Antibodies
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014