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

Phase 3

Terminated

• Conditions: Anemia; Chronic Kidney Disease
• Interventions: Drug: Darbepoetin alfa; Drug: Placebo

• Registration Number: NCT00364845
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2006-08-14
• Study First Submitted QC: 2006-08-15
• Study First Posted: 2006-08-16
• Study Start: 2006-09
• Primary Completion: 2008-12
• Study Completion: 2009-02
• Results First Submitted: 2010-12-02
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-23
• Last Update Submitted: 2014-04-23
• Results First Posted: 2014-05-21
• Last Update Posted: 2014-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24	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

Name	Time	Method
Number of Participants With Hemoglobin (Hb) ≥ 110 g/L	Evaluation Period (Weeks 22-36)	Number of participants achieving a Hemoglobin (Hb) value ≥ 110 g/L during the evaluation period.
Mean Hemoglobin During the Evaluation Period	Evaluation Period (Weeks 22-36)
Euroqol 5 Dimension (EQ-5D) Utility Score at Week 24	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.