Trial information
COMFORT Study: A Crossover Study of NeoRecormon (Epoetin Beta) and Darbepoetin Alfa in Patients With Renal Anemia.
Status: Completed
Protocol number: ML20339
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A Randomised, Cross-Over Study to Investigate the Comfort of Injection of Renal Anaemia Patients Receiving Subcutaneous NeoRecormon® Compared to Darbepoetin Alfa.
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. Target sample size is 50.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Single Blind; Active; Crossover; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: epoetin beta [NeoRecormon]
Primary outcome: 1. Local pain due to s.c. injection (by VAS). Time frame: After each injection
Key secondary outcomes: 1. Patient preference. Time frame: At end of study
2. AEs, vital signs. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 09/18/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Adelaide
- Gosford
- Liverpool
- Parkville
- St. Leonards
- Sydney
- Woolloongabba
