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

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ClinicalTrials.gov Identifier: NCT01543477
Recruitment Status : Active, not recruiting
First Posted : March 5, 2012
Last Update Posted : March 15, 2018
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease
Renal Anemia Pregnancy Lactation

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.

Study Design
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Study Type : Observational
Actual Enrollment : 4502 participants
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)
Actual Study Start Date : July 2010
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Single group


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


Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
Pre-dose serum samples

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


  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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: March 5, 2012    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Anemia
Hematologic Diseases