Post-Authorisation Safety Cohort Observation of Retacrit™ (epoetin zeta) Administered Subcutaneously for the Treatment of Renal Anaemia (PASCO II) (PASCOII)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41085
• EU PAS number:
  EUPAS4276
• Study ID:
  41085
• Official title and acronym:
  Post-Authorisation Safety Cohort Observation of Retacrit™ (epoetin zeta) Administered Subcutaneously for the Treatment of Renal Anaemia (PASCO II) (PASCOII)
• DARWIN EU® study:
  No
• Study countries:
  Bulgaria

  Croatia

  Denmark

  Finland

  France

  Germany

  Greece

  Ireland

  Italy

  Portugal

  Spain

  Sweden

  United Kingdom
• Study description:
  PASCOII is a non-interventional PASS study initiated by the MAH Hospira as part of the RMP. The primary objective of the study is to estimate the incidence of pure red cell aplasia, neutralising antibodies, lack of efficacy and thromboembolic events in renal anaemia. The secondary objective is to obtain information on adverse drug reactions, use of epoetin zeta during pregnancy and lactation and data on long term use.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 198 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 25/05/2010

Actual: 25/05/2010

Study start date

Planned: 07/07/2010

Actual: 07/07/2010

Data analysis start date

Actual: 02/06/2020

Date of final study report

Planned: 12/10/2022

Actual: 06/11/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Hospira UK Limited (a Pfizer Company)

Study protocol

Initial protocol

PASCO II Protocol Version 4.0_20 March 2015_Signed

Updated protocol

C1111006 Protocol Amendment 4 (clean) 02 August 2019

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)