Kidney Disease Clinical Trial
Official title:
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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