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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by The University of Hong Kong.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01150201
First received: June 23, 2010
Last updated: June 25, 2010
Last verified: June 2010

June 23, 2010
June 25, 2010
July 2009
December 2012   (final data collection date for primary outcome measure)
Rate of change in GFR [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01150201 on ClinicalTrials.gov Archive Site
Change in proteinuria [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Disease
  • Drug: Aliskiren
    For CKD treatment
    Other Name: Rasilez
  • Drug: Losartan
    Control
    Other Name: Cozaar
  • Experimental: Aliskiren
    Aliskiren
    Intervention: Drug: Aliskiren
  • Active Comparator: Losartan
    ARB
    Intervention: Drug: Losartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
December 2012
December 2012   (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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01150201
Novartis-ST-02
No
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
June 2010

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