Aliskiren for Immunoglobulin A (IgA) Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00870493
• Date of registration: 26/03/2009
• Prospective Registration: Yes
• Primary sponsor: Chinese University of Hong Kong
• Public title: Aliskiren for Immunoglobulin A (IgA) Nephropathy
• Scientific title: The Safety and Short-Term Efficacy of Aliskiren in the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study
• Date of first enrolment: April 2009
• Target sample size: 22
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00870493
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Hong Kong

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

IgA Nephropathy

Intervention(s)

Drug: Placebo

Drug: Aliskiren

Primary Outcome(s)

change in the degree of proteinuria [Time Frame: 16 weeks]

Secondary Outcome(s)

change in serum and urinary inflammatory markers [Time Frame: 16 weeks]

rate of decline of estimated GFR [Time Frame: 16 weeks]

Secondary ID(s)

AIgA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors