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

Roche

Status and phase: Completed; Phase 4

Conditions: Anemia

Treatments: Drug: darbepoetin alfa; Drug: epoetin beta [NeoRecormon]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00377481

ML20339

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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48 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: epoetin beta [NeoRecormon]

2

Active Comparator group

Treatment:

Drug: darbepoetin alfa