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

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ClinicalTrials.gov Identifier: NCT00377481
Recruitment Status : Completed
First Posted : September 18, 2006
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Anemia Drug: darbepoetin alfa Drug: epoetin beta [NeoRecormon] Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
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.
Study Start Date : September 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

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


Outcome Measures
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Primary Outcome Measures :
  1. Local pain due to s.c. injection (by VAS). [ Time Frame: After each injection ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00377481    
Other Study ID Numbers: ML20339
First Posted: September 18, 2006    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Darbepoetin alfa
Hematinics