STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients

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

Detailed Description
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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.

Official Title
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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.

Conditions
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Anemia, Chronic Kidney Disease

Intervention / Treatment
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* Drug: Darbepoetin alfa
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Darbepoetin alfa<br>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<br>* 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.<br>* Other names: Aranesp®;|
| Placebo Comparator: Placebo<br>Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months. | Drug: Placebo<br>* Prefilled syringe placebo, to match active arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life, Chronic Kidney Disease, Anemia