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/NCT00081471




Registration number
NCT00081471
Ethics application status
Date submitted
13/04/2004
Date registered
16/04/2004
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis
Scientific title
A Randomized, Open-label Study of the Effect of Subcutaneous Mircera on Hemoglobin Level/Correction in Non-dialysis Patients With Chronic Kidney Disease
Secondary ID [1] 0 0
BA16738
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
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Blood 0 0 0 0
Anaemia

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

Experimental: 1 -

Active comparator: 2 -


Treatment: Drugs: darbepoetin alfa
0.45 micrograms/kg sc (starting dose) weekly

Treatment: Drugs: methoxy polyethylene glycol-epoetin beta [Mircera]
0.6 micrograms/kg sc (starting dose) once every 2 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hemoglobin response rate
Timepoint [1] 0 0
Weeks 1-28
Secondary outcome [1] 0 0
Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\n
Timepoint [1] 0 0
Throughout study

Eligibility
Key inclusion criteria
* adult patients >=18 years of age;
* chronic kidney disease;
* anemia;
* not on dialysis therapy;
* not receiving epoetin.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* women who are pregnant, breastfeeding or using unreliable birth control methods;
* administration of another investigational drug within 4 weeks before screening, or during the study period.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/06/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2006
Sample size
Target
Accrual to date
Final
324
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Clayton
Recruitment hospital [2] 0 0
- Liverpool
Recruitment hospital [3] 0 0
- Parkville
Recruitment hospital [4] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
3186 - Clayton
Recruitment postcode(s) [2] 0 0
1871 - Liverpool
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment postcode(s) [4] 0 0
6847 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Connecticut
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United States of America
State/province [3] 0 0
Florida
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United States of America
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Louisiana
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Massachusetts
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United States of America
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Michigan
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New York
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Vermont
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Virginia
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West Virginia
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Antwerpen
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Leuven
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British Columbia
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Manitoba
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Newfoundland and Labrador
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Ontario
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Quebec
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Saskatchewan
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Angers
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Besancon
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Chartres
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Lyon
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Toulouse
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Germany
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Aschaffenburg
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Germany
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Bonn
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Dortmund
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Düsseldorf
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Germany
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Tübingen
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Alexandroupolis
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Athens
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Ioannina
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Piraeus
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Thessaloniki
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Cuneo
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Genova
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Lecco
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Lodi
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Modena
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Napoli
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Padova
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Pavia
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Prato
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Reggio Calabria
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Roma
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Netherlands
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Amersfoort
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Heerlen
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San Juan
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Barcelona
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Lerida
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Madrid
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Valencia
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Sweden
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Boras
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Sweden
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Umea
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United Kingdom
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Birmingham
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Carshalton
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Leicester
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United Kingdom
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London

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/NCT00081471