A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients
A Randomized, Controlled, Open-label, Multi-center, Parallel-group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Intravenously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis.
1 other identifier
interventional
673
8 countries
99
Brief Summary
This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. 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 P75+ for phase_3
Started Feb 2004
99 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
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 10, 2004
CompletedFirst Posted
Study publicly available on registry
February 13, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedResults Posted
Study results publicly available
February 29, 2016
CompletedJanuary 13, 2017
September 1, 2016
1.5 years
February 10, 2004
January 29, 2016
November 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period
A time adjusted mean change in Hb concentration was calculated using an Area Under the Curve (AUC) approach, for both periods separately. Change in Hb concentration between the Baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb from the average evaluation period Hb. At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 eligible participants in RO0503821 (1x/4 Weeks); and 180 out of 225 participants in Epoetin (1-3x/Weeks) arm.
Baseline, Week 29 to Week 36
Secondary Outcomes (7)
Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration.
Baseline, Week 29 to Week 36
The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods
Week 1 to Week 36
Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC)
Up to Week 53
Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes
Up to Week 53
Mean Change in Blood Pressure From Baseline at Week 36 and Week 52
Baseline, Week 36 and Week 52
- +2 more secondary outcomes
Study Arms (3)
RO0503821 (1x/2 Weeks)
EXPERIMENTALParticipants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram \[mcg\]) that was based on the Epoetin dose (\<8000, 8000-16000, \>16000 International units \[IU\]/Week) administered during the week preceding the switch to the study drug.
RO0503821 (1x/4 Weeks)
EXPERIMENTALParticipants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (\<8000, 8000-16000, \>16000 IU/Week) administered during the week preceding the switch to the study drug.
Epoetin (1-3x/Weeks)
ACTIVE COMPARATORParticipants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
Interventions
intravenously 3 times weekly for 52 weeks, as prescribed
60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks.
120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 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 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 (99)
Unknown Facility
Birmingham, Alabama, 35211, United States
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Mobile, Alabama, 36608, United States
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Montgomery, Alabama, 36106, United States
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Encino, California, 91356, United States
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Irvine, California, 92868, United States
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Los Angeles, California, 90095, United States
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Monterey Park, California, 91754, United States
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Riverside, California, 92501, United States
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Sacramento, California, 95816-5119, United States
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San Diego, California, 92103-8342, United States
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San Diego, California, 92120, United States
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San Francisco, California, 94117, United States
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San Jose, California, 95116-1906, United States
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Colorado Springs, Colorado, 80909, United States
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Denver, Colorado, 80262, United States
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Lakewood, Colorado, 80260, United States
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Ocala, Florida, 34471, United States
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Pembroke Pines, Florida, 33028, United States
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Atlanta, Georgia, 30342, United States
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Augusta, Georgia, 30901, United States
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Chicago, Illinois, 60612, United States
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Maywood, Illinois, 60153, United States
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Louisville, Kentucky, 40202-1718, United States
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Covington, Louisiana, 70433, United States
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Boston, Massachusetts, 02115, United States
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Boston, Massachusetts, 02215, United States
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Springfield, Massachusetts, 01107, United States
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Detroit, Michigan, 48202-2689, United States
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Brooklyn Center, Minnesota, 55430, United States
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Paterson, New Jersey, 07503, United States
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Albuquerque, New Mexico, 87131, United States
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Brooklyn, New York, 11203, United States
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Great Neck, New York, 11021, United States
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Mineola, New York, 11501, United States
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New York, New York, 10021, United States
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New York, New York, 10128, United States
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Stony Brook, New York, 11794-8161, United States
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The Bronx, New York, 10467, United States
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Chapel Hill, North Carolina, 27599-7155, United States
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Raleigh, North Carolina, 27609, United States
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Winston-Salem, North Carolina, 27157-1023, United States
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Cincinnati, Ohio, 45267-0585, United States
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Toledo, Ohio, 43606, United States
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Portland, Oregon, 97210, United States
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Erie, Pennsylvania, 16502, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15224, United States
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Pittsburgh, Pennsylvania, 15261, United States
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Orangeburg, South Carolina, 29118, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37205, United States
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Nashville, Tennessee, 37232, United States
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Austin, Texas, 78705, United States
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Houston, Texas, 77054, United States
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Houston, Texas, 77099, United States
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San Antonio, Texas, 78229, United States
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Burlington, Vermont, 05401, United States
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Fairfax, Virginia, 22031, United States
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Richmond, Virginia, 23298, United States
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Marshfield, Wisconsin, 54449, United States
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St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Kingston, Ontario, K7L 3N6, Canada
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London, Ontario, N6A 5A5, Canada
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Mississauga, Ontario, L5M 2V8, Canada
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Scarborough Village, Ontario, M1H 3G4, Canada
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Toronto, Ontario, M5G 2C4, Canada
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Toronto, Ontario, M9N 1N8, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Saskatoon, Saskatchewan, S7K 1N4, Canada
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Aubervilliers, 93307, France
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Bordeaux, 33076, France
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La Tronche, 38700, France
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Paris, 75 016, France
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Paris, 75015, France
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Paris, 75651, France
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Toulouse, 31059, France
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Dortmund, 44263, Germany
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Ellwangen, 73479, Germany
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München, 80804, Germany
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Nuremberg, 90431, Germany
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Stuttgart, 70191, Germany
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Wiesbaden, 65191, Germany
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Wiesloch, 69168, Germany
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Como, 22100, Italy
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Lecco, 23900, Italy
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Lodi, 26900, Italy
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Milan, 20162, Italy
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Pavia, 27100, Italy
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Bergen, 5021, Norway
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Levanger, 7600, Norway
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Lillehammer, 2629, Norway
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Trondheim, 7006, Norway
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A Coruña, 15006, Spain
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Barcelona, 08003, Spain
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Madrid, 28007, Spain
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Málaga, 29010, Spain
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Seville, 41013, Spain
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Lausanne, 1003, Switzerland
Unknown Facility
Lausanne, 1011, Switzerland
Related Publications (2)
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: 36791280DERIVEDLevin NW, Fishbane S, Canedo FV, Zeig S, Nassar GM, Moran JE, Villa G, Beyer U, Oguey D; MAXIMA study investigators. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet. 2007 Oct 20;370(9596):1415-21. doi: 10.1016/S0140-6736(07)61599-2.
PMID: 17950856DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
February 10, 2004
First Posted
February 13, 2004
Study Start
February 1, 2004
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
January 13, 2017
Results First Posted
February 29, 2016
Record last verified: 2016-09