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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.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: September 15, 2006
Last updated: November 1, 2016
Last verified: November 2016
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: darbepoetin alfa Drug: epoetin beta [NeoRecormon] Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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:

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 ]

Secondary Outcome Measures:
  • Patient preference. [ Time Frame: At end of study ]
  • AEs, vital signs. [ Time Frame: Throughout study ]

Enrollment: 48
Study Start Date: September 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00377481

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
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00377481     History of Changes
Other Study ID Numbers: ML20339
Study First Received: September 15, 2006
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Hematologic Diseases
Epoetin Alfa
Darbepoetin alfa
Hematinics processed this record on August 18, 2017