A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients
A Randomized, Open-label Study of the Effect of Maintenance Mircera Administered With Pre-filled Syringes on Hemoglobin Levels in Anemic Dialysis Patients With Chronic Kidney Disease
1 other identifier
interventional
336
12 countries
66
Brief Summary
This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months 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
66 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
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedNovember 2, 2016
November 1, 2016
1.7 years
April 13, 2004
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in hemoglobin concentration
Weeks 1-36
Secondary Outcomes (3)
Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration
Weeks 29-36
RBC transfusions
Weeks 1-36
AEs, laboratory parameters, vital signs
Throughout study
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
30, 50 or 90 micrograms iv or sc (starting dose) every 2 weeks
Eligibility Criteria
You may qualify if:
- adult patients \>=18 years of age;
- chronic renal anemia;
- on dialysis therapy for at least 12 weeks before screening;
- receiving iv or sc epoetin for at least 8 weeks before screening.
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 (66)
Unknown Facility
Covina, California, 91723, United States
Unknown Facility
Los Alamitos, California, 90720, United States
Unknown Facility
Los Angeles, California, 90073, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
San Diego, California, 92161, United States
Unknown Facility
Tampa, Florida, 33617, United States
Unknown Facility
Honolulu, Hawaii, 96813, United States
Unknown Facility
South Holland, Illinois, 60473, United States
Unknown Facility
Baton Rouge, Louisiana, 70884, United States
Unknown Facility
Shreveport, Louisiana, 71101, United States
Unknown Facility
Shreveport, Louisiana, 71103, United States
Unknown Facility
Boston, Massachusetts, 02135, United States
Unknown Facility
Kalamazoo, Michigan, 49007, United States
Unknown Facility
Columbus, Mississippi, 39705, United States
Unknown Facility
Tupelo, Mississippi, 38801, United States
Unknown Facility
St Louis, Missouri, 63128, United States
Unknown Facility
Hackensack, New Jersey, 07601, United States
Unknown Facility
Flushing, New York, 11355, United States
Unknown Facility
New York, New York, 10025, United States
Unknown Facility
Orchard Park, New York, 14127, United States
Unknown Facility
Cleveland, Ohio, 44109, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Oregon City, Oregon, 97045, United States
Unknown Facility
Erie, Pennsylvania, 16502, United States
Unknown Facility
Lewistown, Pennsylvania, 17044, United States
Unknown Facility
Philadelphia, Pennsylvania, 19106, United States
Unknown Facility
Philadelphia, Pennsylvania, 19140, United States
Unknown Facility
Philadelphia, Pennsylvania, 19141, United States
Unknown Facility
Columbia, South Carolina, 29209, United States
Unknown Facility
Charlottesville, Virginia, 22908, United States
Unknown Facility
Norfolk, Virginia, 23507-1901, United States
Unknown Facility
Ottawa, Ontario, K1H 7W9, Canada
Unknown Facility
Toronto, Ontario, M5G 2C4, Canada
Unknown Facility
Greenfield Park, Quebec, J4V 2H1, Canada
Unknown Facility
Montreal, Quebec, H3G 1A4, Canada
Unknown Facility
Aix-en-Provence, 13616, France
Unknown Facility
Chambéry, 73011, France
Unknown Facility
Hyères, 83400, France
Unknown Facility
Le Kremlin-Bicêtre, 94275, France
Unknown Facility
Nantes, 44093, France
Unknown Facility
Paris, 75970, France
Unknown Facility
Rouen, 76031, France
Unknown Facility
Erlangen, 91054, Germany
Unknown Facility
München, 80804, Germany
Unknown Facility
Nuremberg, 90431, Germany
Unknown Facility
Como, 22100, Italy
Unknown Facility
Modena, 41100, Italy
Unknown Facility
Pavia, 27100, Italy
Unknown Facility
Rzeszów, 35-055, Poland
Unknown Facility
Warsaw, 02-006, Poland
Unknown Facility
Carnaxide, 2799-523, Portugal
Unknown Facility
Porto, 4099-001, Portugal
Unknown Facility
Setúbal, 2910-446, Portugal
Unknown Facility
Ponce, 00732, Puerto Rico
Unknown Facility
San Juan, 00936-5067, Puerto Rico
Unknown Facility
Alicante, 03010, Spain
Unknown Facility
Madrid, 28007, Spain
Unknown Facility
Kaohsiung City, 833, Taiwan
Unknown Facility
Taichung, 407, Taiwan
Unknown Facility
Taipei, 100, Taiwan
Unknown Facility
Bangkok, Thailand
Unknown Facility
Glasgow, G4 OSF, United Kingdom
Unknown Facility
Hertford, SG1 4AB, United Kingdom
Unknown Facility
London, E1 1BB, United Kingdom
Unknown Facility
Salford, M6 8HD, United Kingdom
Unknown Facility
Swansea, SA6 6NL, 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
March 1, 2006
Study Completion
March 1, 2006
Last Updated
November 2, 2016
Record last verified: 2016-11