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

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.

Sponsors

Lead Sponsor: Amgen

Source Amgen
Brief Summary

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

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.

Overall Status Terminated
Start Date September 2006
Completion Date February 2009
Primary Completion Date December 2008
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24 Week 24
Secondary Outcome
Measure Time Frame
Number of Participants With Hemoglobin (Hb) ≥ 110 g/L Evaluation Period (Weeks 22-36)
Mean Hemoglobin During the Evaluation Period Evaluation Period (Weeks 22-36)
Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24 Week 24
Enrollment 51
Condition
Intervention

Intervention Type: Drug

Intervention Name: Darbepoetin alfa

Description: 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.

Arm Group Label: Darbepoetin alfa

Other Name: Aranesp®

Intervention Type: Drug

Intervention Name: Placebo

Description: Prefilled syringe placebo, to match active arm

Arm Group Label: Placebo

Eligibility

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

Gender: All

Minimum Age: 70 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
MD Study Director Amgen
Verification Date

April 2014

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Darbepoetin alfa

Type: Active Comparator

Description: 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.

Label: Placebo

Type: Placebo Comparator

Description: Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov