An observational study in Renal Anemia, Pregnancy and Lactation, sponsored by Pfizer. Completed at 179 sites in 12 countries. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2020-10-01.
Sponsored by Pfizer · Observational
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.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 4,501 is above the median of 200 across 326 observational studies indexed under Anemia.
Browse Anemia studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients currently under treatment with Retacrit (epoetin zeta) administered subcutaneously for renal anaemia.
Exclusion Criteria:
Incidence Rate of Adverse Events of Special Interest
Ongoing routine doctor visits for 156 weeks
Time frame: 156 weeks
Adverse drug reactions
Descriptive evaluation including incidence rates of adverse drug reactions.
Time frame: 156 weeks
Information on treatment with Retacrit during pregnancy and lactation
Time frame: 156 weeks
Data on long term use
Time frame: 156 weeks
Showing the first 100 of 179 sites across 12 countries.
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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