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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Anemia Chronic Kidney Disease Drug: Darbepoetin alfa Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : September 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Mean Hemoglobin During the Evaluation Period [ Time Frame: Evaluation Period (Weeks 22-36) ]
  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00364845

Sponsors and Collaborators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen Identifier: NCT00364845     History of Changes
Other Study ID Numbers: 20050122
First Posted: August 16, 2006    Key Record Dates
Results First Posted: May 21, 2014
Last Update Posted: May 21, 2014
Last Verified: April 2014

Keywords provided by Amgen:
Quality of Life
Chronic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa