Status:
COMPLETED
Aliskiren Combined With Losartan in Proteinuric, Non-diabetic Chronic Kidney Disease
Lead Sponsor:
The University of Hong Kong
Conditions:
Kidney Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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) Method...
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 the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01150201
Start Date
July 1 2009
End Date
August 1 2014
Last Update
July 3 2015
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, China