Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
22 participants
INTERVENTIONAL
2009-04-30
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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I
each subject will receive oral aliskiren 300 mg/day for 16 weeks, followed by a washout period of 4 weeks, then crossed over to placebo for another 16 weeks
Aliskiren
Aliskiren 300 mg daily oral
Placebo
starch tablet, 300 mg/day
II
each subject will receive placebo for 16 weeks, followed by a washout period of 4 weeks, then crossed over to oral aliskiren 300 mg/day for another 16 weeks
Aliskiren
Aliskiren 300 mg daily oral
Placebo
starch tablet, 300 mg/day
Interventions
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Aliskiren
Aliskiren 300 mg daily oral
Placebo
starch tablet, 300 mg/day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Cheuk-Chun SZETO
Professor
Locations
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Prince of Wales Hospital
Shatin, , Hong Kong
Countries
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References
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Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
Szeto CC, Kwan BC, Chow KM, Leung CB, Li PK. The safety and short-term efficacy of aliskiren in the treatment of immunoglobulin a nephropathy--a randomized cross-over study. PLoS One. 2013 May 10;8(5):e62736. doi: 10.1371/journal.pone.0062736. Print 2013.
Other Identifiers
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AIgA
Identifier Type: -
Identifier Source: org_study_id