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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
History of Changes
  Purpose

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 Intervention Phase
Kidney Disease
 Drug: Aliskiren
Drug: Losartan
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Rate of change in GFR [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in proteinuria [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: July 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren
Aliskiren
 Drug: Aliskiren
For CKD treatment
Other Name: Rasilez
Active Comparator: Losartan
ARB
 Drug: Losartan
Control
Other Name: Cozaar

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01150201

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

No publications provided

Responsible Party: Sydney C.W. TANG/ Clinical Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01150201     History of Changes
Other Study ID Numbers: Novartis-ST-02
Study First Received: June 23, 2010
Last Updated: June 25, 2010
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 21, 2013