Aliskiren for Immunoglobulin A (IgA) Nephropathy

NCT00870493 | Completed Phase 3

• 1 other identifier: AIgA
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

IgA Nephropathy

Keywords

proteinuria; renal failure; glomerulonephritis

Outcome Measures

Primary Outcomes (1)

• change in the degree of proteinuria

  16 weeks

Secondary Outcomes (2)

• rate of decline of estimated GFR

  16 weeks

• change in serum and urinary inflammatory markers

  16 weeks

Study Arms (2)

I

EXPERIMENTAL

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; Drug: Placebo

II

ACTIVE COMPARATOR

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; Drug: Placebo

Interventions

Aliskiren DRUG

Aliskiren 300 mg daily oral

I; II

Placebo DRUG

starch tablet, 300 mg/day

I; II

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (2)

• 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.

  PMID: 38299639 DERIVED

• 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.

  PMID: 23675422 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA; Proteinuria; Renal Insufficiency; Glomerulonephritis

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 27, 2009
• Study Start: April 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 4, 2012

Record last verified: 2012-12

Locations

HK (1)