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| Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia |
| POST-AUTHORISATION SAFETY COHORT OBSERVATION OF RETACRIT (EPOETIN ZETA) ADMINISTERED SUBCUTANEOUSLY FOR THE TREATMENT OF RENAL ANAEMIA (PASCO II) |
| 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. |
| 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. |
| Observational |
Observational Model: Cohort
Time Perspective: Prospective |
| Not Provided |
Retention: Samples Without DNA
Description: Pre-dose serum samples |
| Non-Probability Sample |
| Patients currently under treatment with Retacrit (epoetin zeta) administered subcutaneously for renal anaemia. |
- Renal Anemia
- Pregnancy
- Lactation
|
| Not Provided |
| Single group |
| Not Provided |
|
| |
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| Active, not recruiting |
| 4502 |
| 6700 |
| April 30, 2022 |
| April 30, 2022 (Final data collection date for primary outcome measure) |
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?
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| Sexes Eligible for Study: | All |
|
| Child, Adult, Older Adult |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Bulgaria, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Spain, Sweden, United Kingdom |
| Portugal |
| |
|
| NCT01543477 |
EPOE-09-11
C1111006 ( Other Identifier: Alias Study Number )
PASCO II ( Other Identifier: Alias Study Number ) |
| No |
| Not Provided |
| 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/da.... |
|
| Pfizer |
| Pfizer |
| Hospira, now a wholly owned subsidiary of Pfizer |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
|
| Pfizer |
| October 2019 |
