Aliskiren for Immunoglobulin A (IgA) Nephropathy

IgA Nephropathy Clinical Trial

Official title:

The Safety and Short-Term Efficacy of Aliskiren in the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870493
• Other study ID #: AIgA
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2009
• Last updated: December 3, 2012
• Start date: April 2009
• Est. completion date: July 2012

Study information

• Verified date: December 2012
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Drug:
• Aliskiren
Aliskiren 300 mg daily oral
• Placebo
starch tablet, 300 mg/day

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in the degree of proteinuria		16 weeks	No
Secondary	rate of decline of estimated GFR		16 weeks	No
Secondary	change in serum and urinary inflammatory markers		16 weeks	No