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

NCT01150201 | Completed Phase 4

• 1 other identifier: Novartis-ST-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Disease

Keywords

CKD; proteinuria; eGFR; Progression of chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Rate of change in GFR

  36 months

Secondary Outcomes (1)

• Change in proteinuria

  36 months

Study Arms (2)

Aliskiren

EXPERIMENTAL

Aliskiren

Drug: Aliskiren

Losartan

ACTIVE COMPARATOR

ARB

Drug: Losartan

Interventions

Aliskiren DRUG

For CKD treatment

Also known as: Rasilez

Aliskiren

Losartan DRUG

Control

Also known as: Cozaar

Losartan

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Kidney Diseases; Proteinuria

Interventions

aliskiren; Losartan

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Sydney CW Tang, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 24, 2010
• Study Start: July 1, 2009
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 3, 2015

Record last verified: 2015-07

Locations

CN (1)