Status:
COMPLETED
Aliskiren for Immunoglobulin A (IgA) Nephropathy
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
IgA Nephropathy
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 blo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00870493
Start Date
April 1 2009
End Date
July 1 2012
Last Update
December 4 2012
Active Locations (1)
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1
Prince of Wales Hospital
Shatin, Hong Kong