IgA Nephropathy
Conditions
Keywords
proteinuria, renal failure, glomerulonephritis
Brief 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.
Interventions
DRUGAliskiren
Aliskiren 300 mg daily oral
DRUGPlacebo
starch tablet, 300 mg/day
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in the degree of proteinuria | 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| rate of decline of estimated GFR | 16 weeks |
| change in serum and urinary inflammatory markers | 16 weeks |
Countries
Hong Kong
Outcome results
None listed