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

NCT ID: NCT01150201

Last Updated: 2015-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2014-08-31

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)

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aliskiren

Aliskiren

Group Type: EXPERIMENTAL

Aliskiren

Intervention Type: DRUG

For CKD treatment

Losartan

ARB

Group Type: ACTIVE_COMPARATOR

Losartan

Intervention Type: DRUG

Control

Interventions

Aliskiren

For CKD treatment

Intervention Type: DRUG

Losartan

Control

Intervention Type: DRUG

Other Intervention Names

Rasilez; Cozaar

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

The University of Hong Kong

Principal Investigators

Sydney CW Tang, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Queen Mary Hospital

Hong Kong, , China

Countries

China

Other Identifiers

Novartis-ST-02

Identifier Type: -

Identifier Source: org_study_id