Clinical trial NCT00699348: A Study of Monthly Intravenous C.E.R.A. (Mircera) in Hemodialysis Participants With Chronic Renal Anemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range
timeFrame: Week 17 up to Week 24
Secondary outcomes:
measure: Change in Hemoglobin Concentration Between Reference SVP and EEP
timeFrame: Week -4 up to Week 0 and Week 17 up to Week 24
measure: Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range
timeFrame: Week 17 up to Week 24
measure: Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
timeFrame: Week 17 up to Week 24
measure: Percentage of Participants Requiring Any Dose Adjustment
timeFrame: Week 1 up to Week 16 and Week 17 up to Week 24
measure: Number of Participants With Red Blood Cell Transfusion During the Study
timeFrame: Week -4 up to Week 52
Other outcomes:
Locations:
city: Acireale
country: Italy
city: Ancona
country: Italy
city: Anzio
country: Italy
city: Arenzano
country: Italy
city: Ascoli Piceno
country: Italy
city: Avellino
country: Italy
city: Benevento
country: Italy
city: Bollate
country: Italy
city: Borgomanero
country: Italy
city: Brescia
country: Italy
city: Brindisi
country: Italy
city: Cagliari
country: Italy
city: Castellammare
country: Italy
city: Catania
country: Italy
city: Catania
country: Italy
city: Cernusco Sul Naviglio
country: Italy
city: Chieri
country: Italy
city: Chieti
country: Italy
city: Civitavecchia
country: Italy
city: Cosenza
country: Italy
city: Ferrara
country: Italy
city: Firenze
country: Italy
city: Firenze
country: Italy
city: Foggia
country: Italy
city: Genova
country: Italy
city: La Spezia
country: Italy
city: Lecco
country: Italy
city: Legnano
country: Italy
city: Lodi
country: Italy
city: Lucera
country: Italy
city: Mantova
country: Italy
city: Matera
country: Italy
city: Milano
country: Italy
city: Milazzo
country: Italy
city: Montevarchi
country: Italy
city: Napoli
country: Italy
city: Napoli
country: Italy
city: Nocera Inferiore
country: Italy
city: Novara
country: Italy
city: Nuoro
country: Italy
city: Ostia Lido
country: Italy
city: Palermo
country: Italy
city: Pavia
country: Italy
city: Perugia
country: Italy
city: Piacenza
country: Italy
city: Pisa
country: Italy
city: Ravenna
country: Italy
city: Reggio Emilia
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: San Daniele Del Friuli
country: Italy
city: San Miniato
country: Italy
city: Sassari
country: Italy
city: Taranto
country: Italy
city: Torino
country: Italy
city: Udine
country: Italy
city: Verona
country: Italy
city: Vicenza
country: Italy
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Locatelli 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.