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

Anemia Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00364845
• Other study ID #: 20050122
• Status: Terminated
• Phase: Phase 3
• First received: August 14, 2006
• Last updated: April 23, 2014
• Start date: September 2006
• Est. completion date: February 2009

Study information

• Verified date: April 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: Therapeutic Goods AdministrationCanada: Health CanadaCanada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.
• Placebo
Prefilled syringe placebo, to match active arm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No
Secondary	Mean Hemoglobin During the Evaluation Period		Evaluation Period (Weeks 22-36)	No
Secondary	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	No

External Links

•   AmgenTrials clinical trials website