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

NCT01225445 | Completed Phase 3

• 1 other identifier: HOE 498/6015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• blood pressure

  5 years

• proteinuria

  over 1 g/day

  5 years

• serum creatinine

  5 years

Study Arms (2)

Treatment

EXPERIMENTAL

ramipril 2.5 mg daily

Drug: Ramipril

Control

NO INTERVENTION

Interventions

Ramipril DRUG

2.5 mg daily

Treatment

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Medicine & Therapeutics, Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (1)

• Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

  PMID: 38299639 DERIVED

MeSH Terms

Interventions

Ramipril

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Cheuk Chun Szeto, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: October 21, 2010
• Study Start: April 1, 2002
• Primary Completion: June 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 21, 2010

Record last verified: 2002-04

Locations

HK (1)