A Study of Monthly Intravenous C.E.R.A. (Mircera) in Hemodialysis Participants With Chronic Renal Anemia
CARISMA
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia
2 other identifiers
interventional
351
1 country
60
Brief Summary
This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia. Participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the erythropoietin stimulating agent \[ESA\] dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per deciliter (g/dL). 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 Jul 2008
60 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
June 17, 2008
CompletedFirst Posted
Study publicly available on registry
June 18, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
April 6, 2016
CompletedApril 6, 2016
March 1, 2016
2 years
June 17, 2008
March 8, 2016
March 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range
Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.0 to 12.0 g/dL during the efficacy evaluation period (EEP) was assessed. The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.
Week 17 up to Week 24
Secondary Outcomes (5)
Change in Hemoglobin Concentration Between Reference SVP and EEP
Week -4 up to Week 0 and Week 17 up to Week 24
Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range
Week 17 up to Week 24
Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
Week 17 up to Week 24
Percentage of Participants Requiring Any Dose Adjustment
Week 1 up to Week 16 and Week 17 up to Week 24
Number of Participants With Red Blood Cell Transfusion During the Study
Week -4 up to Week 52
Study Arms (1)
C.E.R.A.
EXPERIMENTALInterventions
Intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms every 4 weeks for 24 weeks.
Eligibility Criteria
You may qualify if:
- Chronic renal anemia;
- Continuous intravenous maintenance erythropoietin stimulating agent (ESA) treatment during previous month;
- Regular long term hemodialysis therapy with the same mode of dialysis for \>=3 months.
You may not qualify if:
- Transfusion of red blood cells during previous 2 months;
- Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
- Active malignant disease (except non-melanoma skin cancer).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Unknown Facility
Acireale, 95024, Italy
Unknown Facility
Ancona, 60121, Italy
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Anzio, 00042, Italy
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Arenzano, 16011, Italy
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Ascoli Piceno, 63100, Italy
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Avellino, 83100, Italy
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Benevento, 82100, Italy
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Bollate, 20021, Italy
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Borgomanero, 28021, Italy
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Brescia, 25123, Italy
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Brindisi, 72100, Italy
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Cagliari, 09100, Italy
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Castellammare di Stabia, 80053, Italy
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Catania, 95124, Italy
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Catania, 95126, Italy
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Cernusco sul Naviglio, 20063, Italy
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Chieri, 10023, Italy
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Chieti, 66013, Italy
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Civitavecchia, 00053, Italy
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Cosenza, 87100, Italy
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Ferrara, 44100, Italy
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Florence, 50011, Italy
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Florence, 50100, Italy
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Foggia, 71100, Italy
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Genova, 16132, Italy
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La Spezia, 19124, Italy
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Lecco, 23900, Italy
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Legnano, 20025, Italy
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Lido di Ostia, 00121, Italy
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Lodi, 26900, Italy
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Lucera, 71036, Italy
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Mantova, 46100, Italy
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Matera, 75100, Italy
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Milan, 20142, Italy
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Milazzo, 98057, Italy
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Montevarchi, 52025, Italy
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Napoli, 80131, Italy
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Napoli, 80137, Italy
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Nocera Inferiore, 84014, Italy
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Novara, 28100, Italy
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Nuoro, 08100, Italy
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Palermo, 90127, Italy
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Pavia, 27100, Italy
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Perugia, 06126, Italy
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Piacenza, 29100, Italy
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Pisa, 56100, Italy
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Ravenna, 48100, Italy
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Reggio Emilia, 42100, Italy
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Roma, 00133, Italy
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Roma, 00149, Italy
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Roma, 00161, Italy
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Roma, 00189, Italy
Unknown Facility
San Daniele del Friuli, 33038, Italy
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San Miniato, 56028, Italy
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Sassari, 07100, Italy
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Taranto, 74100, Italy
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Torino, 10126, Italy
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Udine, 33100, Italy
Unknown Facility
Verona, 37126, Italy
Unknown Facility
Vicenza, 36100, Italy
Related Publications (2)
Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.
PMID: 26965694DERIVEDLocatelli F, Mandolfo S, Menegato Adorati M, Villa G, Tarchini R, Pizzarelli F, Conte F, Guastoni C, Ricciardi B, Crotta A. Efficacy and safety of once-monthly continuous erythropoietin receptor activator in patients with chronic renal anemia. J Nephrol. 2013 Nov-Dec;26(6):1114-21. doi: 10.5301/jn.5000251. Epub 2013 Sep 13.
PMID: 24052462DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2008
First Posted
June 18, 2008
Study Start
July 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
April 6, 2016
Results First Posted
April 6, 2016
Record last verified: 2016-03