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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00377481

Purpose

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.

Condition	Intervention	Phase
Anemia	Drug: epoetin beta [NeoRecormon] Drug: darbepoetin alfa	Phase IV

MedlinePlus related topics: Anemia

Drug Information available for: Epoetin alfa Erythropoietin Epoetin beta Darbepoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Crossover Assignment, Safety/Efficacy Study
Official Title:	A Randomised, Cross-Over Study to Investigate the Comfort of Injection of Renal Anaemia Patients Receiving Subcutaneous NeoRecormon® Compared to Darbepoetin Alfa.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Local pain due to s.c. injection (by VAS). [ Time Frame: After each injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient preference. [ Time Frame: At end of study ] [ Designated as safety issue: No ]
AEs, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	48
Study Completion Date:	April 2007

Arms	Assigned Interventions
1: Experimental	Drug: epoetin beta [NeoRecormon] 6000 IU sc weekly (2 doses)
2: Active Comparator	Drug: darbepoetin alfa 30 micrograms sc weekly (2 doses)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, >18 years of age;
patients with renal anemia or post-transplant anemia.

Exclusion Criteria:

poorly controlled hypertension;
known hypersensitivity to NeoRecormon or darbepoetin alfa.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377481

Locations

Australia

ADELAIDE, Australia, 5011

MELBOURNE, Australia, 3168

PARKVILLE, Australia, 3052

WOOLLOONGABBA, Australia, 4102

ST. LEONARDS, Australia, 2065

GOSFORD, Australia, 2250

LIVERPOOL, Australia, 2170

SYDNEY, Australia, NSW 2148

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Publications indexed to this study:

Roger SD, Suranyi MG, Walker RG, Disney A, Isbel NM, Kairaitis L, Pollock CA, Brown FG, Chow J, Truman MI, Ulyate KA; COMFORT study group. A randomised, cross-over study comparing injection site pain with subcutaneous epoetin beta and subcutaneous darbepoetin alfa in patients with chronic kidney disease. Curr Med Res Opin. 2008 Aug;24(8):2181-7. Epub 2008 Jun 18.

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20339
Study First Received:	September 15, 2006
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00377481
Health Authority:	Australia: Human Research Ethics Committee

Study placed in the following topic categories:

Epoetin Alfa
Hematologic Diseases
Darbepoetin alfa
Anemia

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009