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Aliskiren for Immunoglobulin A (IgA) Nephropathy

This study has been completed.
Information provided by (Responsible Party):
Cheuk-Chun SZETO, Chinese University of Hong Kong Identifier:
First received: March 26, 2009
Last updated: December 3, 2012
Last verified: December 2012
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.

Condition Intervention Phase
IgA Nephropathy
Drug: Aliskiren
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Safety and Short-Term Efficacy of Aliskiren in the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study

Resource links provided by NLM:

Further study details as provided by Cheuk-Chun SZETO, Chinese University of Hong Kong:

Primary Outcome Measures:
  • change in the degree of proteinuria [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • rate of decline of estimated GFR [ Time Frame: 16 weeks ]
  • change in serum and urinary inflammatory markers [ Time Frame: 16 weeks ]

Enrollment: 22
Study Start Date: April 2009
Study Completion Date: July 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: Aliskiren
Aliskiren 300 mg daily oral
Drug: Placebo
starch tablet, 300 mg/day
Active Comparator: 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
Drug: Aliskiren
Aliskiren 300 mg daily oral
Drug: Placebo
starch tablet, 300 mg/day


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00870493

Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cheuk-Chun SZETO, Professor, Chinese University of Hong Kong Identifier: NCT00870493     History of Changes
Other Study ID Numbers: AIgA
Study First Received: March 26, 2009
Last Updated: December 3, 2012

Keywords provided by Cheuk-Chun SZETO, Chinese University of Hong Kong:
renal failure

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulin A
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017