Aliskiren for Immunoglobulin A (IgA) Nephropathy

Last updated: December 3, 2012
Sponsor: Chinese University of Hong Kong
Overall Status: Completed

Phase

3

Condition

Nephropathy

Kidney Disease

Nephritis

Treatment

N/A

Clinical Study ID

NCT00870493
AIgA
  • Ages 18-65
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • aged 18-65 years

  • requires anti-hypertensive therapy

  • renal biopsy within the past 3 years and confirmed the diagnosis of IgA nephropathy

  • proteinuria > 1 g/day (or proteinuria > 1 g/g-Cr) in 3 consecutive samples within 12weeks despite ACE inhibitor or ARB treatment for at least 3 months

  • estimated glomerular filtration rate > 30 ml/min/1.73m2

  • willingness to give written consent and comply with the study protocol

Exclusion

Exclusion Criteria:

  • Patients who are diabetic, and patients with systemic diseases that may cause IgAnephropathy or another nephropathy.

  • Pregnancy, lactating or childbearing potential without effective method of birthcontrol

  • Severe gastrointestinal disorders that interfere with their ability to receive orabsorb oral medication

  • History of malignancy, including leukemia and lymphoma within the past 2 years

  • Systemic infection requiring therapy at study entry

  • Any other severe coexisting disease such as, but not limited to, chronic liverdisease, myocardial infarction, cerebrovascular accident, malignant hypertension

  • History of drug or alcohol abuse within past 2 years

  • Participation in any previous trial on aliskiren or other renin inhibitor

  • Previous treatment with fish oil, steroid, cytotoxic agents, or aldosterone antagonist

  • History of treatment with other drugs that may affect proteinuria within past 2 years

  • Patients receiving treatment of corticosteroid

  • On other investigational drugs within last 30 days

  • History of a psychological illness or condition such as to interfere with thepatient's ability to understand the requirement of the study

  • History of non-compliance

  • Known history of sensitivity or allergy to aliskiren or other renin inhibitor

Study Design

Total Participants: 22
Study Start date:
April 01, 2009
Estimated Completion Date:
July 31, 2012

Connect with a study center

  • Prince of Wales Hospital

    Shatin,
    Hong Kong

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.