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

Phase 4

Completed

• Conditions: Anemia
• Interventions: Drug: epoetin beta [NeoRecormon]; Drug: darbepoetin alfa

• Registration Number: NCT00377481
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-15
• Study First Submitted QC: 2006-09-15
• Study First Posted: 2006-09-18
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	epoetin beta [NeoRecormon]	-
2	darbepoetin alfa	-

Primary Outcome Measures

Name	Time	Method
Local pain due to s.c. injection (by VAS).	After each injection

Secondary Outcome Measures

Name	Time	Method
Patient preference.	At end of study
AEs, vital signs.	Throughout study