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Aliskiren for Immunoglobulin A (IgA) Nephropathy

Primary Purpose

IgA Nephropathy

Status
Completed
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Aliskiren
Placebo
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring proteinuria, renal failure, glomerulonephritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

I

II

Arm Description

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

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

Outcomes

Primary Outcome Measures

change in the degree of proteinuria

Secondary Outcome Measures

rate of decline of estimated GFR
change in serum and urinary inflammatory markers

Full Information

First Posted
March 26, 2009
Last Updated
December 3, 2012
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00870493
Brief Title
Aliskiren for Immunoglobulin A (IgA) Nephropathy
Official Title
The Safety and Short-Term Efficacy of Aliskiren in the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
Keywords
proteinuria, renal failure, glomerulonephritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
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
Arm Title
II
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Aliskiren
Intervention Description
Aliskiren 300 mg daily oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
starch tablet, 300 mg/day
Primary Outcome Measure Information:
Title
change in the degree of proteinuria
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
rate of decline of estimated GFR
Time Frame
16 weeks
Title
change in serum and urinary inflammatory markers
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
23675422
Citation
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.
Results Reference
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Aliskiren for Immunoglobulin A (IgA) Nephropathy

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