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COMFORT Study: A Crossover Study of NeoRecormon (Epoetin Beta) and Darbepoetin Alfa in Patients With Renal Anemia.

NCT00377481 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-11-02

No results posted yet for this study

Summary

This study will assess the comfort of subcutaneous injections of NeoRecormon and darbepoetin alfa (Aranesp) in patients with renal anemia. Eligible patients will be randomized to receive comparable subcutaneous injections of either darbepoetin alfa (30 micrograms) or NeoRecormon (6000IU). They will then be crossed over to the alternative treatment arm for further treatment. After each injection pain will be assessed using the visual analogue scale (VAS) and 6-point verbal rating scale (VRS), and patient preference will be assessed. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.

Conditions

Interventions

DRUG

darbepoetin alfa

30 micrograms sc weekly (2 doses)

DRUG

epoetin beta [NeoRecormon]

6000 IU sc weekly (2 doses)

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

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 NCT00377481 on ClinicalTrials.gov