Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia
NCT01543477
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FOR MORE INFORMATION
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- 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
- Any contraindications as per the current Summary of Product Characteristics (SPC) of
Retacrit™
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Descriptive Information | |||||
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Brief Title | Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia | ||||
Official Title | POST-AUTHORISATION SAFETY COHORT OBSERVATION OF RETACRIT (EPOETIN ZETA) ADMINISTERED SUBCUTANEOUSLY FOR THE TREATMENT OF RENAL ANAEMIA (PASCO II) | ||||
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. | ||||
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 Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples Without DNA Description: Pre-dose serum samples | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Patients currently under treatment with Retacrit (epoetin zeta) administered subcutaneously for renal anaemia. | ||||
Condition |
| ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Single group | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment | 4501 | ||||
Original Estimated Enrollment | 6700 | ||||
Actual Study Completion Date | April 29, 2020 | ||||
Actual Primary Completion Date | April 29, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
| ||||
Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Bulgaria, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Spain, Sweden, United Kingdom | ||||
Removed Location Countries | Portugal | ||||
Administrative Information | |||||
NCT Number | NCT01543477 | ||||
Other Study ID Numbers | EPOE-09-11 C1111006 ( Other Identifier: Alias Study Number ) PASCO II ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Hospira, now a wholly owned subsidiary of Pfizer | ||||
Investigators |
| ||||
PRS Account | Pfizer | ||||
Verification Date | September 2020 |