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Aliskiren Combined With Losartan in Proteinuric, Non-diabetic Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01150201
Recruitment Status : Completed
First Posted : June 24, 2010
Last Update Posted : July 3, 2015
Information provided by:
The University of Hong Kong

Brief Summary:

Study objective: To investigate the potential anti-proteinuric and renoprotective efficacy of aliskiren in addition to losartan in patients at risk of developing end-stage renal disease (ESRD)

Methods: This will be a randomized, double-blind study in which proteinuric, non-diabetic patients with chronic kidney disease (CKD) will be assigned in a 1:1 ratio to one of the following treatment groups for 3 years:

  • Group A: Losartan (Control arm: conventional treatment)*
  • Group B: Aliskiren plus Losartan (Intervention arm)*

    • With optional addition of other anti-hypertensive agents to achieve an optimal target blood pressure of <130/80 mmHg.

Condition or disease Intervention/treatment Phase
Kidney Disease Drug: Aliskiren Drug: Losartan Phase 4

Detailed Description:
Aliskiren is a direct renin inhibitor that has been shown to reduce proteinuria and retard renal deterioration in type 2 diabetic patients with overt nephropathy. However, it is not known if these therapeutic effects can be extended to nondiabetic chronic renal disease. The current study aims to explore this research question by randomly assigning patients with various stages of chronic renal disease to receive either aliskiren on top of losartan, or continuation of losartan.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 4 Study of the Renoprotective Efficacy of Aliskiren in Addition to Angiotensin II Receptor Blocker in Chronic Kidney Disease
Study Start Date : July 2009
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Aliskiren
Drug: Aliskiren
For CKD treatment
Other Name: Rasilez

Active Comparator: Losartan
Drug: Losartan
Other Name: Cozaar

Primary Outcome Measures :
  1. Rate of change in GFR [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Change in proteinuria [ Time Frame: 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female 18 - 80 years of age
  • Presence of nondiabetic CKD stages 3 to 4 as defined by estimated glomerular filtration rate (eGFR by 4-variable MDRD equation) as follows:

    • Stage 3: Moderate decrease in GFR 30-59 mL/min/1.73 sq.m
    • Stage 4: Severe decrease in GFR 15-29 mL/min/1.73 sq.m
    • CKD is defined as either kidney damage or GFR <60 mL/min/1.73 m2 for > 3 months with variations of less than 30% in the 3 months before screening
  • Early-morning urinary protein-to-creatinine ratio of >500 mg/g or 57 mg/mmol on at least 2 occasions four weeks apart
  • Patients who are willing to give written, informed consent

Exclusion Criteria:

  • eGFR < 15 or > 60 ml/min/1.73m2
  • Early-morning urinary protein-to-creatinine ratio of >5000 mg/g or 570 mg/mmol, or urinary protein-to-creatinine ratio of <500 mg/g or 57 mg/mmol
  • Serum K+ > 5.2 mmol/L
  • Presence of bilateral renal artery stenosis
  • Known allergy to losartan or aliskiren
  • Patients who are receiving angiotensin II receptor blocker / angiotensin converting enzyme inhibitor combination within 12 weeks of randomization
  • Concurrent treatment with corticosteroids, nonsteroidal antiinflammatory drugs, or immunosuppressive agent
  • Patients with connective tissue disease or obstructive uropathy
  • Patients with concomitant malignancy or any such conditions that will severely limit life expectancy
  • Female who are pregnant or intending to conceive
  • Female of child-bearing age who are unwilling to practice effective contraception
  • Patients who are unable to give informed consent
  • Patients simultaneously participating in another study or who have participated in another study within the last 30 days of entry into this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01150201

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Queen Mary Hospital
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
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Principal Investigator: Sydney CW Tang, MD The University of Hong Kong

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Responsible Party: Sydney C.W. TANG/ Clinical Associate Professor, The University of Hong Kong Identifier: NCT01150201     History of Changes
Other Study ID Numbers: Novartis-ST-02
First Posted: June 24, 2010    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: July 2015

Keywords provided by The University of Hong Kong:
Progression of chronic kidney disease

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action