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

Phase 3TerminatedNCT00364845

Amgen51 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Anemia Chronic Kidney Disease

Interventions

Darbepoetin alfaDRUG

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.

PlaceboDRUG

Prefilled syringe placebo, to match active arm

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: Week 24

Secondary Outcomes

Number of Participants With Hemoglobin (Hb) ≥ 110 g/L

Number of participants achieving a Hemoglobin (Hb) value ≥ 110 g/L during the evaluation period.

Time frame: Evaluation Period (Weeks 22-36)

Mean Hemoglobin During the Evaluation Period

Time frame: Evaluation Period (Weeks 22-36)

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.

Time frame: Week 24

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.