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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00377481
First received: September 15, 2006
Last updated: May 13, 2009
Last verified: May 2009
History of Changes
  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 4

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

Resource links provided by NLM:

MedlinePlus related topics: Anemia
U.S. FDA Resources

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: June 2007
Arms Assigned Interventions
Experimental: 1 Drug: epoetin beta [NeoRecormon]
6000 IU sc weekly (2 doses)
Active Comparator: 2 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
Gosford, Australia, 2250
Liverpool, Australia, 2170
Melbourne, Australia, 3168
Parkville, Australia, 3052
St. Leonards, Australia, 2065
Sydney, Australia, NSW 2148
Woolloongabba, Australia, 4102
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00377481     History of Changes
Other Study ID Numbers: ML20339
Study First Received: September 15, 2006
Last Updated: May 13, 2009
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Darbepoetin alfa
Hematinics
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013