Aliskiren for Immunoglobulin A (IgA) Nephropathy

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT00870493

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
IgA Nephropathy	Drug: Aliskiren Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (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

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

change in the degree of proteinuria [16 weeks]

Secondary Outcome Measures

rate of decline of estimated GFR [16 weeks]
change in serum and urinary inflammatory markers [16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prince of Wales Hospital	Shatin		Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cheuk-Chun SZETO, Professor, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT00870493

Other Study ID Numbers:

AIgA

First Posted:

Mar 27, 2009

Last Update Posted:

Dec 4, 2012

Last Verified:

Dec 1, 2012

Keywords provided by Cheuk-Chun SZETO, Professor, Chinese University of Hong Kong

proteinuria

renal failure

glomerulonephritis

Additional relevant MeSH terms:

Kidney Diseases

Glomerulonephritis, IGA

Study Results

No Results Posted as of Dec 4, 2012