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

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

September 15, 2006
September 18, 2006
November 2, 2016
September 2006
June 2007   (Final data collection date for primary outcome measure)
Local pain due to s.c. injection (by VAS). [ Time Frame: After each injection ]
Local pain due to s.c. injection, assessed by VAS
Complete list of historical versions of study NCT00377481 on Archive Site
  • Patient preference. [ Time Frame: At end of study ]
  • AEs, vital signs. [ Time Frame: Throughout study ]
Efficacy: VRS and patient preference. Safety: AEs and vital signs.
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COMFORT Study: A Crossover Study of NeoRecormon (Epoetin Beta) and Darbepoetin Alfa in Patients With Renal Anemia.
A Randomised, Cross-Over Study to Investigate the Comfort of Injection of Renal Anaemia Patients Receiving Subcutaneous NeoRecormon® Compared to Darbepoetin Alfa.
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.
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Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Drug: darbepoetin alfa
    30 micrograms sc weekly (2 doses)
  • Drug: epoetin beta [NeoRecormon]
    6000 IU sc weekly (2 doses)
  • Experimental: 1
    Intervention: Drug: epoetin beta [NeoRecormon]
  • Active Comparator: 2
    Intervention: Drug: darbepoetin alfa
Roger SD, Suranyi MG, Walker RG, Disney A, Isbel NM, Kairaitis L, Pollock CA, Brown FG, Chow J, Truman MI, Ulyate KA; COMFORT study group. A randomised, cross-over study comparing injection site pain with subcutaneous epoetin beta and subcutaneous darbepoetin alfa in patients with chronic kidney disease. Curr Med Res Opin. 2008 Aug;24(8):2181-7. doi: 10.1185/03007990802240552. Epub 2008 Jun 18.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2007
June 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP