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

April 23, 2014 updated by: Amgen

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.

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

51

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Evaluation Period (Weeks 22-36)
Mean Hemoglobin During the Evaluation Period
Time Frame: Evaluation Period (Weeks 22-36)
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.
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

August 14, 2006

First Submitted That Met QC Criteria

August 15, 2006

First Posted (Estimate)

August 16, 2006

Study Record Updates

Last Update Posted (Estimate)

May 21, 2014

Last Update Submitted That Met QC Criteria

April 23, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20050122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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