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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150201
• Other study ID #: Novartis-ST-02
• Status: Completed
• Phase: Phase 4
• First received: June 23, 2010
• Last updated: July 2, 2015
• Start date: July 2009
• Est. completion date: August 2014

Study information

• Verified date: July 2015
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Aliskiren
For CKD treatment
• Losartan
Control

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change in GFR		36 months	Yes
Secondary	Change in proteinuria		36 months	Yes