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

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Non-interventional, longitudinal, multi-centre, defined population, prospective observation

Study drug and medical condition

• Name of medicine:
  RETACRIT
• Medical condition to be studied:
  Aplasia pure red cell

  Renal failure

Population studied

• Short description of the study population:
  Patients are eligible for enrolment if the following applies:; 1. Patients treated SC with Retacrit (epoetin zeta) for renal anaemia.; 2. Informed consent given in writing after being provided with detailed information about the characteristics of this observation by the physician.; 3. Patients expected to be available for 3 years of observation; ; Patients are not eligible for enrolment if the following applies:; 1. Any contraindication as per the current SmPC of Retacrit
• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  6700

Study design details

• Main study objective:
  The main objective 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 sub cutaneously in patients with renal anaemia.
• Outcomes:
  Thromboembolic events including cerebrovascular events (e.g. cerebrovascular accident, cerebral infarction, cerebral haemorrhage, transient ischaemic attack), deep vein thrombosis, myocardial infarction and pulmonary embolism. Descriptive evaluation including incidence rates of adverse drug reactions (ADRs).Information on treatment with Retacrit (epoetin zeta) during pregnancy and lactation, and long term use.
• Data analysis plan:
  The incidence rate of adverse events of special interest will be calculated per patient. The ADRs will be evaluated and described including incidence rates.

Documents

Study results

epoe-09-11-abstract

Study report

epoe-09-11-report-body