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

NCT01543477 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4501

Last updated 2020-10-01

No results posted yet for this study

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.

Conditions

  • Renal Anemia
  • Pregnancy
  • Lactation

Sponsors & Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-07
Primary Completion
2020-04-29
Completion
2020-04-29

Countries

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

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01543477 on ClinicalTrials.gov