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Completed

NCT Number: NCT01543477

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

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.

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Key information

Conditions

Renal Anemia Behavior Breast Feeding Feeding Behavior Lactation Pregnancy

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MHAT "Dr. Tota Venkova"AD, Gabrovo, Bulgaria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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™

Treatment and study plan

Primary outcomes

  1. Incidence Rate of Adverse Events of Special Interest

    Time frame: 156 weeks

    Ongoing routine doctor visits for 156 weeks

Secondary outcomes

  1. Adverse drug reactions

    Time frame: 156 weeks

    Descriptive evaluation including incidence rates of adverse drug reactions.

  2. Information on treatment with Retacrit during pregnancy and lactation

    Time frame: 156 weeks

  3. Data on long term use

    Time frame: 156 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

Registry information

Official study title

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

Acronym: PASCO II

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2012
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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