Back to resultsCOMFORT Study: A Crossover Study of NeoRecormon (Epoetin Beta) and Darbepoetin Alfa in Patients With Renal Anemia.
Primary Purpose
Anemia
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
darbepoetin alfa
epoetin beta [NeoRecormon]
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Local pain due to s.c. injection (by VAS).
Secondary Outcome Measures
Patient preference.
AEs, vital signs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00377481
Brief Title
COMFORT Study: A Crossover Study of NeoRecormon (Epoetin Beta) and Darbepoetin Alfa in Patients With Renal Anemia.
Official Title
A Randomised, Cross-Over Study to Investigate the Comfort of Injection of Renal Anaemia Patients Receiving Subcutaneous NeoRecormon® Compared to Darbepoetin Alfa.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
darbepoetin alfa
Intervention Description
30 micrograms sc weekly (2 doses)
Intervention Type
Drug
Intervention Name(s)
epoetin beta [NeoRecormon]
Intervention Description
6000 IU sc weekly (2 doses)
Primary Outcome Measure Information:
Title
Local pain due to s.c. injection (by VAS).
Time Frame
After each injection
Secondary Outcome Measure Information:
Title
Patient preference.
Time Frame
At end of study
Title
AEs, vital signs.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Adelaide
ZIP/Postal Code
5011
Country
Australia
City
Gosford
ZIP/Postal Code
2250
Country
Australia
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
City
Melbourne
ZIP/Postal Code
3168
Country
Australia
City
Parkville
ZIP/Postal Code
3052
Country
Australia
City
St. Leonards
ZIP/Postal Code
2065
Country
Australia
City
Sydney
ZIP/Postal Code
NSW 2148
Country
Australia
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
18565240
Citation
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.
Results Reference
derived
Learn more about this trial
COMFORT Study: A Crossover Study of NeoRecormon (Epoetin Beta) and Darbepoetin Alfa in Patients With Renal Anemia.
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