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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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Florida
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United States of America
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Louisiana
Country [5] 0 0
United States of America
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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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United States of America
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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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Belgium
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Antwerpen
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Belgium
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Leuven
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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France
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Angers
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France
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Besancon
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France
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Chartres
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France
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Colmar
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France
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Lille
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France
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Lyon
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France
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Nantes
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France
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Paris
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France
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Perpignan
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France
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Salouel
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France
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Toulouse
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France
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Vandoeuvre-les-nancy
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Germany
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Aschaffenburg
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Dortmund
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Germany
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Düsseldorf
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Germany
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Tübingen
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Greece
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Alexandroupolis
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Greece
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Athens
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Greece
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Ioannina
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Greece
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Piraeus
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Greece
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Thessaloniki
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Italy
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Cagliari
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Italy
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Cuneo
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Italy
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Genova
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Italy
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Lecco
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Italy
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Lodi
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Italy
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Modena
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Italy
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Napoli
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Italy
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Padova
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Italy
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Pavia
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Italy
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Prato
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Italy
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Reggio Calabria
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Italy
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Roma
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Netherlands
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Amersfoort
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Netherlands
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Heerlen
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Puerto Rico
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San Juan
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Spain
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Almería
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Spain
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Barcelona
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Spain
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Lerida
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Spain
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Madrid
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Spain
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Palma de Mallorca
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Spain
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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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United Kingdom
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Carshalton
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United Kingdom
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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
This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of
renal anemia in patients with chronic kidney disease who are not on dialysis and not
receiving epoetin or any other erythropoietic substance. The anticipated time on study
treatment is 1-2 years and the target sample size is 100-500 individuals.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00081471
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00081471