Back to resultsSTIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients
Primary Purpose
Anemia, Chronic Kidney Disease
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Darbepoetin alfa
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring Quality of Life, Chronic Kidney Disease, Anemia
Eligibility Criteria
Inclusion Criteria: Stage 3-5 CKD not on dialysis Patients ≥ 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Darbepoetin alfa
Placebo
Arm Description
Single-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.
Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Number of Participants With Hemoglobin (Hb) ≥ 110 g/L
Number of participants achieving a Hemoglobin (Hb) value ≥ 110 g/L during the evaluation period.
Mean Hemoglobin During the Evaluation Period
Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24
The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00364845
Brief Title
STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
The reason for the discontinuation of the study is difficulty with recruitment and timely enrolment and is not related to safety concerns
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety follow up phase of 52 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 patients for 36 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Chronic Kidney Disease
Keywords
Quality of Life, Chronic Kidney Disease, Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Darbepoetin alfa
Arm Type
Active Comparator
Arm Description
Single-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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
Intervention Type
Drug
Intervention Name(s)
Darbepoetin alfa
Other Intervention Name(s)
Aranesp®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Prefilled syringe placebo, to match active arm
Primary Outcome Measure Information:
Title
Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24
Description
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).
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Number of Participants With Hemoglobin (Hb) ≥ 110 g/L
Description
Number of participants achieving a Hemoglobin (Hb) value ≥ 110 g/L during the evaluation period.
Time Frame
Evaluation Period (Weeks 22-36)
Title
Mean Hemoglobin During the Evaluation Period
Time Frame
Evaluation Period (Weeks 22-36)
Title
Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24
Description
The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status.
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage 3-5 CKD not on dialysis
Patients ≥ 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients
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