Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia

Completed

• Conditions: Renal Anemia; Pregnancy; Lactation

• Registration Number: NCT01543477
• Lead Sponsor: Pfizer

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 Timeline

• Study Start: 2010-07-07
• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-02-27
• Study First Posted: 2012-03-05
• Primary Completion: 2020-04-29
• Study Completion: 2020-04-29
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-29
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4501

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™

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence Rate of Adverse Events of Special Interest	156 weeks	Ongoing routine doctor visits for 156 weeks

Secondary Outcome Measures

Name	Time	Method
Data on long term use	156 weeks
Adverse drug reactions	156 weeks	Descriptive evaluation including incidence rates of adverse drug reactions.
Information on treatment with Retacrit during pregnancy and lactation	156 weeks

Trial Locations

Locations (165)

MHAT "Dr. Tota Venkova"AD; 🇧🇬 Gabrovo, Bulgaria

MHAT "Dr. Stamen Iliev"AD; 🇧🇬 Montana, Bulgaria

UMHAT "Georgi Stranski" EAD; 🇧🇬 Pleven, Bulgaria

Dutchmed Dialysis Clinic (in the building of 5 DCC); 🇧🇬 Plovdiv, Bulgaria

MHAT Plodiv AD; 🇧🇬 Plovdiv, Bulgaria

MHAT "Dr. Bratan Shukerov" AD; 🇧🇬 Smolian, Bulgaria

Fifth MHAT EAD; 🇧🇬 Sofia, Bulgaria

Acibadem City Clinic Tokuda Hospital EAD MHAT "Tokuda Hospital Sofia"; 🇧🇬 Sofia, Bulgaria

University Hospital Lozenets; 🇧🇬 Sofia, Bulgaria

UMHAT "Alexandrovska" EAD; 🇧🇬 Sofia, Bulgaria

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