Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia (PASCO II)

Pfizer

Status: Completed

Conditions: Renal Anemia; Lactation; Pregnancy

Study type: Observational

Funder types: Industry

Identifiers

NCT01543477

PASCO II (Other Identifier)

C1111006 (Other Identifier)

EPOE-09-11

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4,501 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients currently under treatment with Retacrit™ (epoetin zeta) administered subcutaneously for renal anaemia.
• Informed consent given in writing after being provided with detailed information about the characteristics of this observation by the physician.
• Patients expected to be available for 3 years of observation

Exclusion criteria

• Any contraindications as per the current Summary of Product Characteristics (SPC) of Retacrit™

Trial design

4,501 participants in 1 patient group

Single group