NCT01543477

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

POST-AUTHORISATION SAFETY COHORT OBSERVATION OF RETACRIT (EPOETIN ZETA) ADMINISTERED SUBCUTANEOUSLY FOR THE TREATMENT OF RENAL ANAEMIA (PASCO II)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,501 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Renal Anemia
• Pregnancy
• Lactation

Timeline

• Start date: 2010-07-07
• Primary completion: 2020-04-29
• Completion: 2020-04-29
• First posted: 2012-03-05
• Last updated: 2020-10-01

Locations

179 sites across 12 countries: Bulgaria, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Spain, Sweden, United Kingdom