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

Anemia Clinical Trial

Official title:

A Randomised, Cross-Over Study to Investigate the Comfort of Injection of Renal Anaemia Patients Receiving Subcutaneous NeoRecormon® Compared to Darbepoetin Alfa.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00377481
• Other study ID #: ML20339
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2006
• Last updated: November 1, 2016
• Start date: September 2006
• Est. completion date: June 2007

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• darbepoetin alfa
30 micrograms sc weekly (2 doses)
• epoetin beta [NeoRecormon]
6000 IU sc weekly (2 doses)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local pain due to s.c. injection (by VAS).		After each injection	No
Secondary	Patient preference.		At end of study	No
Secondary	AEs, vital signs.		Throughout study	No