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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:
ClinicalTrials.gov Identifier:
NCT00377481
First Posted: September 18, 2006
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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: 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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00377481     History of Changes
Other Study ID Numbers: ML20339
First Submitted: September 15, 2006
First Posted: September 18, 2006
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Darbepoetin alfa
Hematinics