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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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00377481
First received: September 15, 2006
Last updated: June 3, 2013
Last verified: June 2013
History of Changes

September 15, 2006
June 3, 2013
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 ] [ Designated as safety issue: No ]
Local pain due to s.c. injection, assessed by VAS
Complete list of historical versions of study NCT00377481 on ClinicalTrials.gov Archive Site
  • 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 ]
Efficacy: VRS and patient preference. Safety: AEs and vital signs.
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Anemia
  • Drug: epoetin beta [NeoRecormon]
    6000 IU sc weekly (2 doses)
  • Drug: darbepoetin alfa
    30 micrograms 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. Epub 2008 Jun 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00377481
ML20339
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
June 2013

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