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STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients
This study has been terminated.
(The reason for the discontinuation of the study is difficulty with recruitment and timely enrolment and is not related to safety concerns)
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00364845
First received: August 14, 2006
Last updated: April 23, 2014
Last verified: April 2014
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Purpose
Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety follow up phase of 52 weeks
| Condition | Intervention | Phase |
|---|---|---|
| Anemia Chronic Kidney Disease | Drug: Darbepoetin alfa Drug: Placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Participant) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- 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).
Secondary Outcome Measures:
- 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.
| Enrollment: | 51 |
| Study Start Date: | September 2006 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Placebo
Prefilled syringe placebo, to match active arm
|
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.
Eligibility| Ages Eligible for Study: | 70 Years and older (Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364845
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364845
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00364845 History of Changes |
| Other Study ID Numbers: |
20050122 |
| Study First Received: | August 14, 2006 |
| Results First Received: | December 2, 2010 |
| Last Updated: | April 23, 2014 |
Keywords provided by Amgen:
|
Quality of Life Chronic Kidney Disease Anemia |
Additional relevant MeSH terms:
|
Anemia Kidney Diseases Renal Insufficiency, Chronic Hematologic Diseases |
Urologic Diseases Renal Insufficiency Darbepoetin alfa Hematinics |
ClinicalTrials.gov processed this record on July 17, 2017