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Clinical Trial Details

Trial ID: L0505
Source ID: NCT00364845
Associated Drug: Darbepoetin Alfa
Title: STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00364845/results
Conditions: Anemia|Chronic Kidney Disease
Interventions: DRUG: Darbepoetin alfa|DRUG: Placebo
Outcome Measures: Primary: 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: Number of Participants With Hemoglobin (Hb) ≥ 110 g/L, Number of participants achieving a Hemoglobin (Hb) value ≥ 110 g/L during the evaluation period., 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, 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., Week 24
Sponsor/Collaborators: Sponsor: Amgen
Gender: ALL
Age: OLDER_ADULT
Phases: PHASE3
Enrollment: 51
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2006-09
Completion Date: 2009-02
Results First Posted: 2014-05-21
Last Update Posted: 2014-05-21
Locations:
URL: https://clinicaltrials.gov/show/NCT00364845