NCT00377481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

September 15, 2006

Last Update Submit

November 1, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Local pain due to s.c. injection (by VAS).

    After each injection

Secondary Outcomes (2)

  • Patient preference.

    At end of study

  • AEs, vital signs.

    Throughout study

Study Arms (2)

1

EXPERIMENTAL
Drug: epoetin beta [NeoRecormon]

2

ACTIVE COMPARATOR
Drug: darbepoetin alfa

Interventions

darbepoetin alfaDRUG

30 micrograms sc weekly (2 doses)

2
epoetin beta [NeoRecormon]DRUG

6000 IU sc weekly (2 doses)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients, \>18 years of age;
  • patients with renal anemia or post-transplant anemia.

You may not qualify if:

  • poorly controlled hypertension;
  • known hypersensitivity to NeoRecormon or darbepoetin alfa.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Adelaide, 5011, Australia

Location

Unknown Facility

Gosford, 2250, Australia

Location

Unknown Facility

Liverpool, 2170, Australia

Location

Unknown Facility

Melbourne, 3168, Australia

Location

Unknown Facility

Parkville, 3052, Australia

Location

Unknown Facility

St Leonards, 2065, Australia

Location

Unknown Facility

Sydney, NSW 2148, Australia

Location

Unknown Facility

Woolloongabba, 4102, Australia

Location

Related Publications (1)

  • 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.

    PMID: 18565240DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Darbepoetin alfaepoetin beta

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2006

First Posted

September 18, 2006

Study Start

September 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

AU(8)