MedTrace Logo

Aliskiren for Immunoglobulin A (IgA) Nephropathy

NCT00870493 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2012-12-04

No results posted yet for this study

Summary

Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in the world. Current treatment with angiotensin converting enzyme (ACE) inhibitor and angiotensin receptor blocker (ARB) is not entirely effective. Aliskiren, a direct renin inhibitor, acts on the rate limiting step of the renin-angiotensin axis. In addition to lowering the blood pressure, recent study in diabetic nephropathy suggests an independent anti-proteinuric effect. The investigators plan to conduct a randomized placebo-control cross-over study to evaluate the safety and efficacy of aliskiren in the treatment of IgA nephropathy. The investigators plan to recruit 57 patients with biopsy-proven IgA nephropathy and persistent proteinuria despite conventional therapy. They will be randomized to aliskiren for 16 weeks or no treatment, followed by cross over to the other arm after a washout period. Proteinuria, albuminuria, renal function, serum and urinary markers will be quantified. This study will explore the potential anti-proteinuric effect of aliskiren in the treatment of IgA nephropathy, which has no specific treatment at present.

Conditions

Interventions

DRUG

Aliskiren

Aliskiren 300 mg daily oral

DRUG

Placebo

starch tablet, 300 mg/day

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-03-31
Completion
2012-07-31

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00870493 on ClinicalTrials.gov