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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 August 2017 by Pfizer
Sponsor:
Pfizer
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01543477
First received: February 21, 2012
Last updated: August 10, 2017
Last verified: August 2017
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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 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 2010 |
| Estimated Study Completion Date: | April 2022 |
| Estimated Primary Completion Date: | April 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| 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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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 179 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 ) |
| Study First Received: | February 21, 2012 |
| Last Updated: | August 10, 2017 |
Additional relevant MeSH terms:
|
Anemia Hematologic Diseases |
ClinicalTrials.gov processed this record on August 17, 2017