Overview

Aliskiren for Immunoglobulin A (IgA) Nephropathy

Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chinese University of Hong Kong
Treatments:
Antibodies
Immunoglobulin A
Immunoglobulins
Criteria
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 12
weeks 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 Criteria:

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

- Pregnancy, lactating or childbearing potential without effective method of birth
control

- Severe gastrointestinal disorders that interfere with their ability to receive or
absorb 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 liver
disease, 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 the
patient'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