A Study of Subcutaneous 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 Subcutaneously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis
1 other identifier
interventional
572
21 countries
90
Brief Summary
This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc 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 Mar 2004
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2004
CompletedFirst Posted
Study publicly available on registry
February 13, 2004
CompletedStudy Start
First participant enrolled
March 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedResults Posted
Study results publicly available
April 26, 2016
CompletedMay 25, 2016
April 1, 2016
1.5 years
February 10, 2004
March 24, 2016
April 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods
A time adjusted mean change in hemoglobin (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 value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36.
Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)
Secondary Outcomes (8)
Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration
Evaluation period (Week 29 to Week 36)
Number of Participants With Red Blood Cell Transfusions
Up to Week 36
Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths
Up to week 52
Number of Participants With Marked Laboratory Abnormalities
Up to week 52
Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants
From Baseline (Week -4 to Week -1) to Week 36 and Week 52
- +3 more secondary outcomes
Study Arms (3)
RO0503821 (1x/2 Weeks)
EXPERIMENTALEligible participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 international units (IU)/week, administered during the week preceding the switch to the study drug.
RO0503821 (1x/4 Weeks)
EXPERIMENTALEligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug.
Epoetin Reference
ACTIVE COMPARATOREligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks .
Interventions
60, 100 or 180 micrograms 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 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 (90)
Unknown Facility
Hot Springs, Arkansas, 71901, United States
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Los Angeles, California, 90033, 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 Jose, California, 95116-1906, United States
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Boston, Massachusetts, 02130, 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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Raleigh, North Carolina, 27609, United States
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Winston-Salem, North Carolina, 27157-1023, United States
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Toledo, Ohio, 43606, United States
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Portland, Oregon, 97210, United States
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Dallas, Texas, 75216, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78229, United States
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Morgantown, West Virginia, 26506, United States
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Brussels, 1090, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Hasselt, 3500, Belgium
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Curitiba, 81050-090, Brazil
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São Paulo, 03065-000, Brazil
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São Paulo, 04039-000, Brazil
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Brno, 656 91, Czechia
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Ostrava, 708 52, Czechia
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Pilsen, 304 60, Czechia
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Odense, 5000, Denmark
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HUS, 00029, Finland
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Tampere, 33521, Finland
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Turku, 20521, Finland
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Bayonne, 64115, France
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Boulogne, 62321, France
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Cabestany, 66330, France
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Caen, 14033, France
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Limoges, 87042, France
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Nîmes, 30029, France
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Pantin, 93500, France
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Poitiers, 86021, France
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Saint-Germain-en-Laye, 78100, France
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Saint-Priest-en-Jarez, 42055, France
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Thionville, 57126, France
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Tours, 37044, France
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Bad Hersfeld, 36251, Germany
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Berlin, 12045, Germany
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Kaiserslautern, 67655, Germany
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Budapest, 1076, Hungary
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Budapest, 1134, Hungary
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Debrecen, 4032, Hungary
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Miskolc, 3526, Hungary
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Pécs, 7624, Hungary
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Cremona, 26100, Italy
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Lecco, 23900, Italy
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Mestre, 30174, Italy
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Modena, 41100, Italy
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Prato, 50047, Italy
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Venezia, 30122, Italy
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Cuernavaca, 62448, Mexico
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Mexico City, 14000, Mexico
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Christchurch, New Zealand
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Wellington, New Zealand
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Panama City, 0, Panama
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Gdansk, 80-211, Poland
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Kielce, 25-736, Poland
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Krakow, 31-501, Poland
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Wroclaw, 50-417, Poland
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Ponce, 00732, Puerto Rico
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Durban, South Africa
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Alcorcón, 28922, Spain
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Barcelona, 08035, Spain
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Madrid, 28006, Spain
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Madrid, 28046, Spain
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Palma de Mallorca, 07198, Spain
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Pamplona, 31008, Spain
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Santiago de Compostela, 15706, Spain
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Huddinge, 14186, Sweden
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Karlstad, 65185, Sweden
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Taichung, 407, Taiwan
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Taipei, 100, Taiwan
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Bangkok, 10310, Thailand
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Bangkok, 10400, Thailand
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Phitsanulok, 65000, Thailand
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Belfast, BT9 7LJ, United Kingdom
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Cambridge, CB2 2QQ, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Exeter, EX2 5DW, 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
Unknown Facility
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)
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
March 1, 2004
Primary Completion
September 1, 2005
Study Completion
September 1, 2005
Last Updated
May 25, 2016
Results First Posted
April 26, 2016
Record last verified: 2016-04