STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients
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|ClinicalTrials.gov Identifier: NCT00364845|
Recruitment Status : Terminated (The reason for the discontinuation of the study is difficulty with recruitment and timely enrolment and is not related to safety concerns)
First Posted : August 16, 2006
Results First Posted : May 21, 2014
Last Update Posted : May 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Anemia Chronic Kidney Disease||Drug: Darbepoetin alfa Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||September 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||February 2009|
Active Comparator: Darbepoetin alfa
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.
Drug: Darbepoetin alfa
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.
Other Name: Aranesp®
Placebo Comparator: Placebo
Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
Prefilled syringe placebo, to match active arm
- Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24 [ Time Frame: 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).
- Number of Participants With Hemoglobin (Hb) ≥ 110 g/L [ Time Frame: Evaluation Period (Weeks 22-36) ]Number of participants achieving a Hemoglobin (Hb) value ≥ 110 g/L during the evaluation period.
- Mean Hemoglobin During the Evaluation Period [ Time Frame: Evaluation Period (Weeks 22-36) ]
- Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00364845