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:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00364845
First received: August 14, 2006
Last updated: April 23, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

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
Health Authority: Australia: Human Research Ethics Committee
Australia: Therapeutic Goods Administration
Canada: Health Canada
Canada: Institutional Review Board

Keywords provided by Amgen:
Quality of Life
Chronic Kidney Disease
Anemia

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014