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 (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00377481
First received: September 15, 2006
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This study will assess the comfort of subcutaneous injections of NeoRecormon and darbepoetin alfa (Aranesp) in patients with renal anemia. Eligible patients wil l be randomized to receive comparable subcutaneous injections of either darbepoe tin alfa (30 micrograms) or NeoRecormon (6000IU). They will then be crossed over to the alternative treatment arm for further treatment. After each injection pa in will be assessed using the visual analogue scale (VAS) and 6-point verbal ra ting 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
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:


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 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

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
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 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: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00377481     History of Changes
Other Study ID Numbers: ML20339
Study First Received: September 15, 2006
Last Updated: October 6, 2014
Health Authority: Australia: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on October 23, 2014