Study Stopped
The reason for the discontinuation of the study is difficulty with recruitment and timely enrolment and is not related to safety concerns
STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients
A Randomised Single-Blind Study to Improve Health-related Quality of Life as Measured by the Short-Form 36 (SF-36) Vitality Score by Correcting Anemia With Aranesp (Darbepoetin Alfa) in the Elderly.
1 other identifier
interventional
51
0 countries
N/A
Brief Summary
Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety follow up phase of 52 weeks
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2006
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2006
CompletedFirst Posted
Study publicly available on registry
August 16, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
May 21, 2014
CompletedMay 21, 2014
April 1, 2014
2.3 years
August 14, 2006
December 2, 2010
April 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).
Week 24
Secondary Outcomes (3)
Number of Participants With Hemoglobin (Hb) ≥ 110 g/L
Evaluation Period (Weeks 22-36)
Mean Hemoglobin During the Evaluation Period
Evaluation Period (Weeks 22-36)
Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24
Week 24
Study Arms (2)
Darbepoetin alfa
ACTIVE COMPARATORSingle-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
Placebo
PLACEBO COMPARATORSingle-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
Interventions
Starting dose was calculated at 0.75 micrograms per kilogram (μg/kg) body weight at randomization, rounded to nearest prefilled syringe dose unit. Dose was titrated incrementally. Monthly dose was initially double the every 2 week dose at time of conversion.
Eligibility Criteria
You may qualify if:
- Stage 3-5 CKD not on dialysis
- Patients ≥ 70 years of age
- Haemoglobin \< 110g/L at screening
- Transferrin saturation ≥ 15% at screening
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (1)
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PMID: 36791280DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2006
First Posted
August 16, 2006
Study Start
September 1, 2006
Primary Completion
December 1, 2008
Study Completion
February 1, 2009
Last Updated
May 21, 2014
Results First Posted
May 21, 2014
Record last verified: 2014-04