POST-AUTHORISATION SAFETY COHORT OBSERVATION OF RETACRIT (EPOETIN ZETA) ADMINISTERED SUBCUTANEOUSLY FOR THE TREATMENT OF RENAL ANAEMIA (PASCO II)
POST-AUTHORISATION SAFETY COHORT OBSERVATION OF RETACRIT (EPOETIN ZETA) ADMINISTERED SUBCUTANEOUSLY FOR THE TREATMENT OF RENAL ANAEMIA (PASCO II)
The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia. The other key objective of this study is to obtain information on adverse drug reactions (ADR) associated with Retacrit™ (epoetin zeta), use of epoetin zeta during pregnancy and lactation and data on long term use.
This is a non-interventional, multi-centre, longitudinal observation with a defined population using a prospective cohort design to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia.
Inclusion Criteria:
Exclusion Criteria:
Amiens (Salouel) Cedex 1, 80054, France
Amiens (Salouel) Cedex 1, 80054, France
Herne, 44623, Germany
Hürth-Hermülheim, 50354, Germany
Didimoticho, 683 00, Greece
Mesologgi, 30200, Greece
Nea Raidestos, Thessaloniki, 57001, Greece
Zingonia- Osio Sotto, Bergamo 24040, Italy
Santa Maria Capua Vetere, CE 81055, Italy
Cona-Ferrara, Ferrara 44124, Italy
San Miniato, PISA 56027, Italy
Lido Di Camaiore (Lucca), 55043, Italy
Milan, 20126, Italy
Naples, 80131, Italy
Naples, 80131, Italy
Naples, 80131, Italy
PISA (Cisanello), 56124, Italy
Siena, 53100, Italy
Torino, 10126, Italy