Aliskiren Combined With Losartan in Proteinuric, Non-diabetic Chronic Kidney Disease
July 2, 2015 updated by: The University of Hong Kong
Phase 4 Study of the Renoprotective Efficacy of Aliskiren in Addition to Angiotensin II Receptor Blocker in Chronic Kidney Disease
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, China
- Queen Mary Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Aliskiren
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For CKD treatment
Other Names:
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Active Comparator: Losartan
ARB
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Control
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of change in GFR
Time Frame: 36 months
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36 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in proteinuria
Time Frame: 36 months
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36 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
June 23, 2010
First Submitted That Met QC Criteria
June 23, 2010
First Posted (Estimate)
June 24, 2010
Study Record Updates
Last Update Posted (Estimate)
July 3, 2015
Last Update Submitted That Met QC Criteria
July 2, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Novartis-ST-02
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