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STIMULATE Study: Anemia Correction and HRQoL Outcomes in Elderly CKD Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Amgen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00364845
First received: August 14, 2006
Last updated: September 30, 2010
Last verified: September 2010
History of Changes
  Purpose

Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety follow up phase of 52 weeks


Condition Intervention Phase
Anemia
Chronic Kidney Disease
 Drug: Darbepoetin alfa
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomised Single-Blind Study to Improve Health-related Quality of Life as Measured by the SF-36 Vitality Score by Correcting Anemia With Aranesp (Darbepoetin Alfa) in the Elderly.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • SF-36 vitality subscale score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of subjects achieving a Hb greater than or equal to 110g/L [ Time Frame: 22-36 weeks ] [ Designated as safety issue: No ]
  • Mean Hb [ Time Frame: 22-36 weeks ] [ Designated as safety issue: No ]
  • SF-36 subscale scores, FACT-An subscale scores and EQ-5D scores [ Time Frame: 12, 24 and 36 weeks ] [ Designated as safety issue: No ]
  • Grip strength [ Time Frame: 12, 24 and 36 weeks ] [ Designated as safety issue: No ]
  • Lower extremity function [ Time Frame: 12, 24 and 36 weeks ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: August 2006
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Drug: Darbepoetin alfa
Subjects randomised to active treatment group receive darbepoetin alfa sc Q2W until Hb is stabilised, then move to QM dosing for remainder of treatment period (36 weeks maximum) . Starting dose is calculated at 0.75ug/kg body weight at randomisation, rounded to nearest prefilled syringe dose unit. Dose is titrated incrementally. QM dose is initially double the Q2W dose at time of conversion. Doses available are 10,15,20,30,40,50,60,80,100,150,200 and 300ug, administered via prefilled syringe.
Placebo Comparator: Placebo Drug: Placebo
Subjects randomised to placebo group have Q2W dosing (prefilled syringe placebo sc, to match active arm) for 16 weeks, followed by QM dosing for remainder of treatment period (ie maximum of 36 weeks).

Detailed Description:

This is a multicentre, randomised, single-blind, placebo-controlled, two-arm parallel group study assessing the effect of anaemia correction and Hb maintenance with darbepoetin alfa in elderly CKD subjects over 36 weeks.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage 3-5 CKD not on dialysis
  • Subjects >= 70 years of age
  • Haemoglobin < 110g/L at screening
  • Transferrin saturation >= 15% at screening

Exclusion Criteria:

  • Clinical history of type 2 diabetes mellitus
  • Anticipating or scheduled to go on renal replacement therapy in the next year, including renal transplant
  • Uncontrolled hypertension on two separate measurements during screening
  • Use of any erythropoietic protein within 12 weeks of screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364845

Locations
Australia, New South Wales
Research Site
Gosford, New South Wales, Australia
Research Site
Hornsby, New South Wales, Australia
Research Site
Liverpool, New South Wales, Australia
Research Site
Nambour, New South Wales, Australia
Research Site
St Leonards, New South Wales, Australia
Australia, South Australia
Research Site
Adelaide, South Australia, Australia
Australia
Research Site
Box Hill, Australia
Research Site
Footscray, Australia
Research Site
Fremantle, Australia
Research Site
Heidelberg West, Australia
Research Site
Herston, Australia
Research Site
Launceston, Australia
Research Site
Perth, Australia
Research Site
Prahran, Australia
Canada, Alberta
Research Site
Calgary, Alberta, Canada
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Research Site
Courtice, Ontario, Canada
Research Site
Oakville, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Canada, Quebec
Research Site
Greenfield Park, Quebec, Canada
Research Site
Verdun, Quebec, Canada
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00364845     History of Changes
Other Study ID Numbers: 20050122
Study First Received: August 14, 2006
Last Updated: September 30, 2010
Health Authority: Australia: Human Research Ethics Committee
Australia: Therapeutic Goods Administration
Canada: Health Canada
Canada: Institutional Review Board

Keywords provided by Amgen:
Quality of Life
Chronic Kidney Disease
Anemia

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
 Renal Insufficiency
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013