NCT01150201

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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) 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.

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.

Conditions

• Kidney Disease

Interventions

Type	Name	Description
DRUG	Aliskiren	For CKD treatment
DRUG	Losartan	Control

Timeline

• Start date: 2009-07-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2010-06-24
• Last updated: 2015-07-03

Locations

1 site across 1 country: China