A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis
A Randomized, Open-label Study of the Effect of Subcutaneous Mircera on Hemoglobin Level/Correction in Non-dialysis Patients With Chronic Kidney Disease
1 other identifier
interventional
324
13 countries
98
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2004
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2004
CompletedFirst Posted
Study publicly available on registry
April 16, 2004
CompletedStudy Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedNovember 2, 2016
November 1, 2016
2.1 years
April 13, 2004
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Hemoglobin response rate
Weeks 1-28
Secondary Outcomes (1)
Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\n
Throughout study
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
0.6 micrograms/kg sc (starting dose) once every 2 weeks
Eligibility Criteria
You may qualify if:
- adult patients \>=18 years of age;
- chronic kidney disease;
- anemia;
- not on dialysis therapy;
- not receiving epoetin.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (98)
Unknown Facility
Los Angeles, California, 90073, United States
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Mather, California, 95655, United States
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Stanford, California, 94305-5114, United States
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Stamford, Connecticut, 06902, United States
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Bay Pines, Florida, 33744, United States
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Ocala, Florida, 34471, United States
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Shreveport, Louisiana, 71101, United States
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Boston, Massachusetts, 02135, United States
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Boston, Massachusetts, 02215, United States
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Detroit, Michigan, 48236, United States
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Flushing, New York, 11355, United States
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Cincinnati, Ohio, 45220, United States
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Portland, Oregon, 97201-2940, United States
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Allentown, Pennsylvania, 18103, United States
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Columbia, South Carolina, 29209, United States
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Nashville, Tennessee, 37232, United States
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Austin, Texas, 78705, United States
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Dallas, Texas, 75216, United States
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Houston, Texas, 77054, United States
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Burlington, Vermont, 05401, United States
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Salem, Virginia, 24153, United States
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Morgantown, West Virginia, 26506, United States
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Clayton, 3186, Australia
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Liverpool, 1871, Australia
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Parkville, 3052, Australia
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Perth, 6847, Australia
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Antwerp, 2060, Belgium
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Leuven, 3000, Belgium
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Calgary, Alberta, T2N 2T9, Canada
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Edmonton, Alberta, T6G 2B7, Canada
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Kamloops, British Columbia, V2C 2T1, Canada
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New Westminster, British Columbia, V3L 3W7, Canada
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Vancouver, British Columbia, V6Z 1Y6, Canada
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Winnipeg, Manitoba, R2H 2A6, Canada
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St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Kitchener, Ontario, N2G 1N9, Canada
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London, Ontario, N6A 5A5, Canada
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Scarborough Village, Ontario, M1H 3G4, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2C4, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Saskatoon, Saskatchewan, S7K 1N4, Canada
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Angers, 49933, France
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Besançon, 25030, France
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Chartres, 28000, France
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Colmar, 68024, France
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Lille, 59037, France
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Lyon, 69437, France
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Nantes, 44035, France
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Paris, 75743, France
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Paris, 75908, France
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Perpignan, 66046, France
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Salouël, 80480, France
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Toulouse, 31059, France
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Vandœuvre-lès-Nancy, 54511, France
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Aschaffenburg, 63741, Germany
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Berlin, 13353, Germany
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Bonn, 53127, Germany
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Dortmund, 44263, Germany
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Düsseldorf, 40225, Germany
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Tübingen, 72076, Germany
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Alexandroupoli, 68100, Greece
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Athens, 11527, Greece
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Ioannina, 455 00, Greece
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Piraeus, 18536, Greece
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Thessaloniki, 54629, Greece
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Cagliari, 91034, Italy
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Cuneo, 12100, Italy
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Genova, 16132, Italy
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Lecco, 23900, Italy
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Lodi, 26900, Italy
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Modena, 41100, Italy
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Napoli, 80131, Italy
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Padua, 35128, Italy
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Pavia, 27100, Italy
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Prato, 50047, Italy
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Reggio Calabria, 89124, Italy
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Roma, 00184, Italy
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Amersfoort, 3818, Netherlands
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Heerlen, 6419 PC, Netherlands
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San Juan, 00936-5067, Puerto Rico
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Almería, 04009, Spain
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Barcelona, 08907, Spain
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Lleida, 25198, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Madrid, 28805, Spain
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Palma de Mallorca, 07014, Spain
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Valencia, 46017, Spain
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Borås, 50142, Sweden
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Umeå, 90185, Sweden
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Birmingham, B9 5SS, United Kingdom
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Carshalton, SM5 1AA, United Kingdom
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Leicester, LE5 4PW, United Kingdom
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London, SE1 9RT, United Kingdom
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London, SE22 8PT, United Kingdom
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London, SW17 0RE, United Kingdom
Related Publications (1)
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PMID: 36791280DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2004
First Posted
April 16, 2004
Study Start
June 1, 2004
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
November 2, 2016
Record last verified: 2016-11