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

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NCT01543477

Last updated on August 22, 2018
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FOR MORE INFORMATION
Study Location
MHAT "Dr. Tota Venkova"AD
Gabrovo, , 5300 Bulgaria
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Anemia, Pregnancy, Lactation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Any contraindications as per the current Summary of Product Characteristics (SPC) of
Retacrit?

NCT01543477
Pfizer
Active, not recruiting
Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia

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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 (tm) (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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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?
Sexes Eligible for Study: All
Child, Adult, Senior
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
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
Not Provided
Pfizer
Pfizer
Hospira, now a wholly owned subsidiary of Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

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