- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00377481
COMFORT Study: A Crossover Study of NeoRecormon (Epoetin Beta) and Darbepoetin Alfa in Patients With Renal Anemia.
November 1, 2016 updated by: Hoffmann-La Roche
A Randomised, Cross-Over Study to Investigate the Comfort of Injection of Renal Anaemia Patients Receiving Subcutaneous NeoRecormon® Compared to Darbepoetin Alfa.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Adelaide, Australia, 5011
-
Gosford, Australia, 2250
-
Liverpool, Australia, 2170
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Melbourne, Australia, 3168
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Parkville, Australia, 3052
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St. Leonards, Australia, 2065
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Sydney, Australia, NSW 2148
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Woolloongabba, Australia, 4102
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
6000 IU sc weekly (2 doses)
|
Active Comparator: 2
|
30 micrograms sc weekly (2 doses)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Local pain due to s.c. injection (by VAS).
Time Frame: After each injection
|
After each injection
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient preference.
Time Frame: At end of study
|
At end of study
|
AEs, vital signs.
Time Frame: Throughout study
|
Throughout study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
September 15, 2006
First Submitted That Met QC Criteria
September 15, 2006
First Posted (Estimate)
September 18, 2006
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML20339
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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