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NCT Number: NCT00870493

Aliskiren for Immunoglobulin A (IgA) Nephropathy

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.

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Key information

Conditions

IgA Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Pathological Conditions, Signs and Symptoms Proteinuria Renal Insufficiency Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aliskiren

Drug

Aliskiren 300 mg daily oral

Placebo

Drug

starch tablet, 300 mg/day

Primary outcomes

  1. change in the degree of proteinuria

    Time frame: 16 weeks

Secondary outcomes

  1. rate of decline of estimated GFR

    Time frame: 16 weeks

  2. change in serum and urinary inflammatory markers

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 27, 2009
Registry last updated
Dec 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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