STIMULATE Study: Anemia Correction and HRQoL Outcomes in Elderly CKD Patients - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00364845

Purpose

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

Condition	Intervention	Phase
Anemia Chronic Kidney Disease	Drug: Darbepoetin alfa Drug: Placebo	Phase III

MedlinePlus related topics: Anemia

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title:	A Randomised Single-Blind Study to Improve Health-Related Quality of Life as Measured by the SF-36 Vitality Score by Correcting Anemia With Aranesp (Darbepoetin Alfa) in the Elderly.

Further study details as provided by Amgen:

Primary Outcome Measures:

SF-36 vitality subscale score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The proportion of subjects achieving a Hb greater than or equal to 110g/L [ Time Frame: 22-36 weeks ] [ Designated as safety issue: No ]
Mean Hb [ Time Frame: 22-36 weeks ] [ Designated as safety issue: No ]
SF-36 subscale scores, FACT-An subscale scores and EQ-5D scores [ Time Frame: 12, 24 and 36 weeks ] [ Designated as safety issue: No ]
Grip strength [ Time Frame: 12, 24 and 36 weeks ] [ Designated as safety issue: No ]
Lower extremity function [ Time Frame: 12, 24 and 36 weeks ] [ Designated as safety issue: No ]

Enrollment:	51
Study Start Date:	August 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Active Comparator	Drug: Darbepoetin alfa Subjects randomised to active treatment group receive darbepoetin alfa sc Q2W until Hb is stabilised, then move to QM dosing for remainder of treatment period (36 weeks maximum) . Starting dose is calculated at 0.75ug/kg body weight at randomisation, rounded to nearest prefilled syringe dose unit. Dose is titrated incrementally. QM dose is initially double the Q2W dose at time of conversion. Doses available are 10,15,20,30,40,50,60,80,100,150,200 and 300ug, administered via prefilled syringe.
Placebo: Placebo Comparator	Drug: Placebo Subjects randomised to placebo group have Q2W dosing (prefilled syringe placebo sc, to match active arm) for 16 weeks, followed by QM dosing for remainder of treatment period (ie maximum of 36 weeks).

Arms

Assigned Interventions

Active: Active Comparator

Drug: Darbepoetin alfa

Subjects randomised to active treatment group receive darbepoetin alfa sc Q2W until Hb is stabilised, then move to QM dosing for remainder of treatment period (36 weeks maximum) . Starting dose is calculated at 0.75ug/kg body weight at randomisation, rounded to nearest prefilled syringe dose unit. Dose is titrated incrementally. QM dose is initially double the Q2W dose at time of conversion. Doses available are 10,15,20,30,40,50,60,80,100,150,200 and 300ug, administered via prefilled syringe.

Placebo: Placebo Comparator

Drug: Placebo

Subjects randomised to placebo group have Q2W dosing (prefilled syringe placebo sc, to match active arm) for 16 weeks, followed by QM dosing for remainder of treatment period (ie maximum of 36 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 subjects over 36 weeks.

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stage 3-5 CKD not on dialysis
Subjects >= 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364845

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050122
Study First Received:	August 14, 2006
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00364845
Health Authority:	Australia: Human Research Ethics Committee; Australia: Therapeutic Goods Administration; Canada: Health Canada; Canada: Institutional Review Board

Keywords provided by Amgen:

Quality of Life
Chronic Kidney Disease
Anemia

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Hematologic Diseases
Renal Insufficiency, Chronic
Darbepoetin alfa

Anemia
Kidney Failure, Chronic
Quality of Life
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009