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

Normal Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225445
• Other study ID #: HOE 498/6015
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2010
• Last updated: October 20, 2010
• Start date: April 2002
• Est. completion date: October 2010

Study information

• Verified date: April 2002
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biopsy-confirmed IgA Nephropathy
• Glomerulonephritis, IGA
• Kidney Diseases
• Normal Blood Pressure
• Proteinuria
• Proteinuria Less Than 0.5 g Per Day
• Serum Creatinine Below 120 Umol/l

Intervention

Drug:
• Ramipril
2.5 mg daily

Locations

Country	Name	City	State
Hong Kong	Department of Medicine & Therapeutics, Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure		5 years	No
Primary	proteinuria	over 1 g/day	5 years	No
Primary	serum creatinine		5 years	No