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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01543477
Recruitment Status : Completed
First Posted : March 5, 2012
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

Study Description
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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 : 4501 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: POST-AUTHORISATION SAFETY COHORT OBSERVATION OF RETACRIT (EPOETIN ZETA) ADMINISTERED SUBCUTANEOUSLY FOR THE TREATMENT OF RENAL ANAEMIA (PASCO II)
Actual Study Start Date : July 7, 2010
Actual Primary Completion Date : April 29, 2020
Actual Study Completion Date : April 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

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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Ages Eligible for Study:   Child, Adult, Older Adult
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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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


Locations
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Sponsors and Collaborators
Pfizer
Hospira, now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01543477    
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: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases