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.
Study Type
OBSERVATIONAL
Enrollment
4,501
MHAT "Dr. Tota Venkova"AD
Gabrovo, Bulgaria
MHAT "Dr. Stamen Iliev"AD
Montana, Bulgaria
UMHAT "Georgi Stranski" EAD
Pleven, Bulgaria
Dutchmed Dialysis Clinic (in the building of 5 DCC)
Plovdiv, Bulgaria
MHAT Plodiv AD
Plovdiv, Bulgaria
MHAT "Dr. Bratan Shukerov" AD
Incidence Rate of Adverse Events of Special Interest
Ongoing routine doctor visits for 156 weeks
Time frame: 156 weeks
Adverse drug reactions
Descriptive evaluation including incidence rates of adverse drug reactions.
Time frame: 156 weeks
Information on treatment with Retacrit during pregnancy and lactation
Time frame: 156 weeks
Data on long term use
Time frame: 156 weeks
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Smolyan, Bulgaria
Fifth MHAT EAD
Sofia, Bulgaria
Acibadem City Clinic Tokuda Hospital EAD MHAT "Tokuda Hospital Sofia"
Sofia, Bulgaria
University Hospital Lozenets
Sofia, Bulgaria
UMHAT "Alexandrovska" EAD
Sofia, Bulgaria
...and 169 more locations