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

June 23, 2010
June 24, 2010
July 3, 2015
July 2009
August 2014   (Final data collection date for primary outcome measure)
Rate of change in GFR [ Time Frame: 36 months ]
Same as current
Complete list of historical versions of study NCT01150201 on Archive Site
Change in proteinuria [ Time Frame: 36 months ]
Same as current
Not Provided
Not Provided
Aliskiren Combined With Losartan in Proteinuric, Non-diabetic Chronic Kidney Disease
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.
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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Disease
  • Drug: Aliskiren
    For CKD treatment
    Other Name: Rasilez
  • Drug: Losartan
    Other Name: Cozaar
  • Experimental: Aliskiren
    Intervention: Drug: Aliskiren
  • Active Comparator: Losartan
    Intervention: Drug: Losartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2014
August 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Sydney C.W. TANG/ Clinical Associate Professor, The University of Hong Kong
The University of Hong Kong
Not Provided
Principal Investigator: Sydney CW Tang, MD The University of Hong Kong
The University of Hong Kong
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP