Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00377481




Registration number
NCT00377481
Ethics application status
Date submitted
15/09/2006
Date registered
18/09/2006
Date last updated
2/11/2016

Titles & IDs
Public title
COMFORT Study: A Crossover Study of NeoRecormon (Epoetin Beta) and Darbepoetin Alfa in Patients With Renal Anemia.
Scientific title
A Randomised, Cross-Over Study to Investigate the Comfort of Injection of Renal Anaemia Patients Receiving Subcutaneous NeoRecormon® Compared to Darbepoetin Alfa.
Secondary ID [1] 0 0
ML20339
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anemia 0 0
Condition category
Condition code
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - darbepoetin alfa
Treatment: Drugs - epoetin beta [NeoRecormon]

Experimental: 1 -

Active comparator: 2 -


Treatment: Drugs: darbepoetin alfa
30 micrograms sc weekly (2 doses)

Treatment: Drugs: epoetin beta [NeoRecormon]
6000 IU sc weekly (2 doses)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Local pain due to s.c. injection (by VAS).
Timepoint [1] 0 0
After each injection
Secondary outcome [1] 0 0
Patient preference.
Timepoint [1] 0 0
At end of study
Secondary outcome [2] 0 0
AEs, vital signs.
Timepoint [2] 0 0
Throughout study

Eligibility
Key inclusion criteria
* adult patients, >18 years of age;
* patients with renal anemia or post-transplant anemia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* poorly controlled hypertension;
* known hypersensitivity to NeoRecormon or darbepoetin alfa.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2007
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Gosford
Recruitment hospital [3] 0 0
- Liverpool
Recruitment hospital [4] 0 0
- Melbourne
Recruitment hospital [5] 0 0
- Parkville
Recruitment hospital [6] 0 0
- St. Leonards
Recruitment hospital [7] 0 0
- Sydney
Recruitment hospital [8] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
3168 - Melbourne
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
2065 - St. Leonards
Recruitment postcode(s) [7] 0 0
NSW 2148 - Sydney
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00377481