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

NCT ID: NCT00377481

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-06-30

Brief Summary

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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

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Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

epoetin beta [NeoRecormon]

Intervention Type DRUG

6000 IU sc weekly (2 doses)

2

Group Type ACTIVE_COMPARATOR

darbepoetin alfa

Intervention Type DRUG

30 micrograms sc weekly (2 doses)

Interventions

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darbepoetin alfa

30 micrograms sc weekly (2 doses)

Intervention Type DRUG

epoetin beta [NeoRecormon]

6000 IU sc weekly (2 doses)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Adelaide, , Australia

Site Status

Gosford, , Australia

Site Status

Liverpool, , Australia

Site Status

Melbourne, , Australia

Site Status

Parkville, , Australia

Site Status

St Leonards, , Australia

Site Status

Sydney, , Australia

Site Status

Woolloongabba, , Australia

Site Status

Countries

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Australia

References

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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. doi: 10.1185/03007990802240552. Epub 2008 Jun 18.

Reference Type DERIVED
PMID: 18565240 (View on PubMed)

Other Identifiers

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ML20339

Identifier Type: -

Identifier Source: org_study_id