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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01543477

Acronym

PASCO II

Enrollment

4501

Registered

2012-03-05

Start date

2010-07-07

Completion date

2020-04-29

Last updated

2020-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lactation, Pregnancy, Renal Anemia

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to No maximum

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™

Design outcomes

Primary

Measure	Time frame	Description
Incidence Rate of Adverse Events of Special Interest	156 weeks	Ongoing routine doctor visits for 156 weeks

Secondary

Measure	Time frame	Description
Data on long term use	156 weeks	—
Adverse drug reactions	156 weeks	Descriptive evaluation including incidence rates of adverse drug reactions.
Information on treatment with Retacrit during pregnancy and lactation	156 weeks	—

Countries

Bulgaria, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Spain, Sweden, United Kingdom

Outcome results