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

Primary Purpose

Kidney Disease

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Aliskiren

Losartan

About this trial

This is an interventional treatment trial for Kidney Disease focused on measuring CKD, proteinuria, eGFR, Progression of chronic kidney disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Queen Mary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aliskiren

Losartan

Arm Description

Aliskiren

ARB

Outcomes

Primary Outcome Measures

Rate of change in GFR

Secondary Outcome Measures

Change in proteinuria

Full Information

NCT ID

NCT01150201

First Posted

June 23, 2010

Last Updated

July 2, 2015

Sponsor

The University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT01150201

Brief Title

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

Official Title

Phase 4 Study of the Renoprotective Efficacy of Aliskiren in Addition to Angiotensin II Receptor Blocker in Chronic Kidney Disease

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

The University of Hong Kong

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Disease

Keywords

CKD, proteinuria, eGFR, Progression of chronic kidney disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aliskiren

Arm Type

Experimental

Arm Description

Aliskiren

Arm Title

Losartan

Arm Type

Active Comparator

Arm Description

ARB

Intervention Type

Drug

Intervention Name(s)

Aliskiren

Other Intervention Name(s)

Rasilez

Intervention Description

For CKD treatment

Intervention Type

Drug

Intervention Name(s)

Losartan

Other Intervention Name(s)

Cozaar

Intervention Description

Control

Primary Outcome Measure Information:

Title

Rate of change in GFR

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Change in proteinuria

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sydney CW Tang, MD

Organizational Affiliation

The University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Queen Mary Hospital

City

Hong Kong

Country

China

12. IPD Sharing Statement

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

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