A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients
A Randomized, Controlled, Open Label, Multicenter, Parallel-group Study to Compare the Effect of Mircera With That of Darbepoetin Alfa, Administered Intravenously at Extended Dosing Intervals, for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Hemodialysis
1 other identifier
interventional
490
13 countries
83
Brief Summary
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. 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 Dec 2006
83 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
November 1, 2006
CompletedFirst Posted
Study publicly available on registry
November 2, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
January 20, 2017
CompletedJanuary 20, 2017
November 1, 2016
1.9 years
November 1, 2006
August 12, 2016
November 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period
Randomized participants with an average hemoglobin (Hb) decrease from Baseline (Week -4 to Week -1) not exceeding 1.0 gram per deciliter (g/dL) and an absolute average Hb \>= 10.5 g/dL during the evaluation period (Weeks 50-53) were defined as responders. Non-responders included participants without any Hb data during the second treatment period and those who did not meet the response criteria and thus were not included in the analysis.
Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53)
Secondary Outcomes (5)
Mean Percentage Change in MIRCERA and Darbepoetin Alpha Dose Over Time
Week 27 to Month 12
Number of Participants With Marked Laboratory Abnormality Over Time
Up to Week 53
Median Blood Pressure Over Time
Baseline (Week -4 to Week -1), Week 28, and Week 52
Mean Pulse Rate Over Time
Baseline (Week -4 to Week -1), Week 28, and Week 52
Number of Participants With Any Adverse Events, Serious Adverse Events, and Deaths
From screening to Week 56
Study Arms (2)
MIRCERA
EXPERIMENTALEligible participants with anemia in CKD who were on hemodialysis will receive methoxy polyethylene glycol-epoetin beta (MIRCERA \[RO0503821\]) IV once every month up to 52 weeks. The starting dose of MIRCERA which will be administered during the treatment period will depend on the dose of darbepoetin alfa administered during screening period i.e., 120, 200 and 360 mcg for weekly darbepoetin alfa doses of \<40, 40-80, and \>80 mcg, respectively.
Darbepoetin Alfa
ACTIVE COMPARATOREligible participants with anemia in CKD who were on hemodialysis will receive darbepoetin alfa (Aranesp) IV once every two weeks up to 26 weeks and darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Interventions
120, 200 or 360 micrograms iv / month, starting dose
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- chronic renal anemia;
- hemodialysis 3 times weekly for \>=12 weeks before screening, and during screening/baseline period;
- receiving darbepoetin alfa maintenance therapy for \>=8 weeks before screening, and during screening/baseline period.
You may not qualify if:
- overt gastrointestinal bleeding within 8 weeks before screening or during screening/baseline period;
- transfusion of red blood cells within 8 weeks before screening or during screening/baseline period;
- active malignancy;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (88)
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Adelaide, SA 5000, Australia
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Clayton, 3186, Australia
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Gosford, 2250, Australia
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Parkville, 3052, Australia
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Woolloongabba, 4102, Australia
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Linz, 4010, Austria
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Vienna, 1090, Austria
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Vienna, 1220, Austria
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Aalst, 9300, Belgium
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Brussels, 1020, Belgium
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Brussels, 1200, Belgium
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Roeselare, 8800, Belgium
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Calgary, Alberta, T2N 2T9, Canada
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Hamilton, Ontario, L8N 4A6, Canada
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Kitchener, Ontario, N2G 1N9, Canada
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Mississauga, Ontario, L5M 2V8, Canada
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Ottawa, Ontario, K1H 7W9, Canada
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Toronto, Ontario, M5G 2C4, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Trois-Rivières, Quebec, G8Z 4K8, Canada
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Aalborg, 9100, Denmark
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Hillerød, 3400, Denmark
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Roskilde, 4000, Denmark
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Tampere, 33521, Finland
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Turku, 20521, Finland
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Auch, 32000, France
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Bordeaux, 33000, France
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Boulogne, 62321, France
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Castelnau-le-Lez, 34170, France
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Cergy-Pontoise, 95303, France
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Chamalières, 63400, France
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Dijon, 21079, France
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Fleury-Mérogis, 91712, France
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Hérouville-Saint-Clair, 14202, France
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La Tronche, 38701, France
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Lyon, 69437, France
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Montpellier, 34295, France
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Nîmes, 30029, France
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Paris, 75015, France
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Paris, 75970, France
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Reims, 51092, France
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Rennes, 35033, France
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Saint-Brieuc, 22027, France
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Saint-Herblain, 44093, France
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Saint-Ouen, 93400, France
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Villeurbanne, 69100, France
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Bad Hersfeld, 36251, Germany
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Bonn, 53127, Germany
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Dortmund, 44263, Germany
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München, 80804, Germany
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Stuttgart, 70191, Germany
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Villingen-Schwenningen, 78054, Germany
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Bologna, 40138, Italy
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Como, 22100, Italy
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Genova, 16132, Italy
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Lecco, 23900, Italy
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Modena, 41100, Italy
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Pavia, 27100, Italy
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Prato, 50047, Italy
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Venezia, 30122, Italy
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Amsterdam, 1081 HV, Netherlands
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Dordrecht, 3318 AT, Netherlands
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Leiria, 2400-441, Portugal
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Alicante, 03010, Spain
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Badalona, 08915, Spain
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Barcelona, 08003, Spain
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Barcelona, 08036, Spain
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Bilbao, 48013, Spain
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Córdoba, 14004, Spain
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León, 24071, Spain
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Madrid, 28003, Spain
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Madrid, 28035, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Madrid, 28222, Spain
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Ourense, 32005, Spain
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Santander, 39008, Spain
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Vigo, 36204, Spain
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Vigo, 36205, Spain
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Aarau, 5001, Switzerland
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Lausanne, 1003, Switzerland
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Belfast, BT9 7LJ, United Kingdom
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Canterbury, CT1 3NE, United Kingdom
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Glasgow, G4 OSF, United Kingdom
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London, SE22 8PT, United Kingdom
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Manchester, M13 9WL, United Kingdom
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Truro, TR1 3LJ, United Kingdom
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: 36791280DERIVEDCarrera F, Lok CE, de Francisco A, Locatelli F, Mann JF, Canaud B, Kerr PG, Macdougall IC, Besarab A, Villa G, Kazes I, Van Vlem B, Jolly S, Beyer U, Dougherty FC; PATRONUS Investigators. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Nephrol Dial Transplant. 2010 Dec;25(12):4009-17. doi: 10.1093/ndt/gfq305. Epub 2010 Jun 3.
PMID: 20522670DERIVED
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
November 1, 2006
First Posted
November 2, 2006
Study Start
December 1, 2006
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
January 20, 2017
Results First Posted
January 20, 2017
Record last verified: 2016-11