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 September 2016 by Pfizer
Sponsor:
Pfizer
Collaborator:
Hospira, Inc.
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01543477
First received: February 21, 2012
Last updated: September 16, 2016
Last verified: September 2016
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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 Pfizer:
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| Ages Eligible for Study: | Child, Adult, Senior |
| 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
Show 172 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543477
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Show 172 Study Locations
Sponsors and Collaborators
Pfizer
Hospira, Inc.
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 |
| Study First Received: | February 21, 2012 |
| Last Updated: | September 16, 2016 |
| 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 September 26, 2016