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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01225445
Enrollment
60
Registered
2010-10-21
Start date
2002-04-30
Completion date
2010-10-31
Last updated
2010-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGRamipril

2.5 mg daily

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
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

Design outcomes

Primary

MeasureTime frameDescription
blood pressure5 years
proteinuria5 yearsover 1 g/day
serum creatinine5 years

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026