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

NCT00364845 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2014-05-21

Study results available
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Summary

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

Conditions

Interventions

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.

DRUG

Placebo

Prefilled syringe placebo, to match active arm

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2008-12-31
Completion
2009-02-28

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00364845 on ClinicalTrials.gov