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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.
Verified November 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT01543477
First Posted: March 5, 2012
Last Update Posted: November 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer
  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 Retacrit (tm) (Epoetin Zeta) Administered Subcutaneously For The Treatment Of Renal Anaemia (Pasco Ii)

Resource links provided by NLM:


Further study details as provided by Pfizer:

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


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

  • Information on treatment with Retacrit during pregnancy and lactation [ Time Frame: 156 weeks ]
  • Data on long term use [ Time Frame: 156 weeks ]

Biospecimen Retention:   Samples Without DNA
Pre-dose serum samples

Estimated Enrollment: 6700
Actual Study Start Date: July 7, 2010
Estimated Study Completion Date: April 30, 2022
Estimated Primary Completion Date: April 30, 2022 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543477


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 179 Study Locations
Sponsors and Collaborators
Pfizer
Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01543477     History of Changes
Other Study ID Numbers: EPOE-09-11
C1111006 ( Other Identifier: Alias Study Number )
PASCO II ( Other Identifier: Alias Study Number )
First Submitted: February 21, 2012
First Posted: March 5, 2012
Last Update Posted: November 30, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Anemia
Hematologic Diseases