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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Hospira, Inc.
Sponsor:
Collaborator:
Hospira UK Ltd.
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01543477
First received: February 21, 2012
Last updated: July 27, 2015
Last verified: July 2015
  Purpose

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.


Condition
Renal Anemia
Pregnancy
Lactation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia (PASCO II)

Resource links provided by NLM:


Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • Incidence Rate of Adverse Events of Special Interest [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
    Ongoing routine doctor visits for 156 weeks


Secondary Outcome Measures:
  • Adverse drug reactions [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
    Descriptive evaluation including incidence rates of adverse drug reactions.

  • Information on treatment with Retacrit during pregnancy and lactation [ Time Frame: 156 weeks ] [ Designated as safety issue: No ]
  • Data on long term use [ Time Frame: 156 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Pre-dose serum samples


Estimated Enrollment: 4500
Study Start Date: July 2010
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Single group

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients currently under treatment with Retacrit (epoetin zeta) administered subcutaneously for renal anaemia.

Criteria

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™
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543477

Contacts
Contact: Heather Fowler, PhD 01204 310 965 heather.fowler@hospira.com
Contact: Paul Audhya, MD MBA +1 224 212 4287 paul.audhya@hospira.com

  Show 204 Study Locations
Sponsors and Collaborators
Hospira, Inc.
Hospira UK Ltd.
  More Information

No publications provided

Responsible Party: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT01543477     History of Changes
Other Study ID Numbers: EPOE-09-11
Study First Received: February 21, 2012
Last Updated: July 27, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Finland: Finnish Medicines Agency
France: Conseil National de l'Ordre des Médecins
France: The Commission nationale de l’informatique et des libertés
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Irish Medicines Board
Italy: The Italian Medicines Agency
Portugal: National Pharmacy and Medicines Institute
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Bulgaria: Bulgarian Drug Agency
Greece: National Organization of Medicines
Croatia: Agency for Medicinal Product and Medical Devices
Denmark: Danish Health and Medicines Authority

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on July 30, 2015