A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA® Or Reference ESAs.
A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA® Or Reference ESAs.
This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not receiving renal replacement therapy under treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta at the following doses: for participants not already receiving ESA treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs in accordance with their prescribed dosing information.
Inclusion Criteria:
Exclusion Criteria:
CABA, 1425, Argentina
Hradec Králové, 500 05, Czechia
Bonn, 53127, Germany
Erlangen, 91054, Germany
Homburg/Saar, 66424, Germany
München, 80804, Germany
Zrifin, 70300, Israel
Ravenna, Emilia-Romagna 48100, Italy
Reggio Emilia, Emilia-Romagna 42100, Italy
Milan, Lombardy 20122, Italy
Milan, Lombardy 20162, Italy
S Fermo Della Battaglia, Lombardy 22020, Italy
LODI, Tuscany 26900, Italy
Castelfranco, Veneto 31033, Italy
Cona (FE), Veneto 44124, Italy
Rovigo, Veneto 45100, Italy
Kuala Lumpur, FED. Territory of Kuala Lumpur 50603, Malaysia
Panama City, 0834-02723, Panama
DÄ…browa Tarnowska, 33-200, Poland
Jasło, 38-200, Poland
Pabianice, 95-200, Poland
Poznan, 61-485, Poland
Sandomierz, 27-600, Poland
Stalowa Wola, 37-450, Poland
Wałbrzych, 58-309, Poland
Saint Petersburg, Sankt-Peterburg 197022, Russia
Saint Petersburg, 191104, Russia
Saint Petersburg, 195067, Russia
Saint Petersburg, 195257, Russia
Uppsala, 75185, Sweden
Coventry, CV2 2DX, United Kingdom
London, NW3 2PF, United Kingdom
West Sussex, BN11 2DH, United Kingdom