Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia (PASCO II)
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ClinicalTrials.gov Identifier: NCT01543477 |
Recruitment Status
:
Active, not recruiting
First Posted
: March 5, 2012
Last Update Posted
: March 15, 2018
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Condition or disease |
---|
Renal Anemia Pregnancy Lactation |
Study Type : | Observational |
Actual Enrollment : | 4502 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Post-authorisation Safety Cohort Observation Of Retacrit (tm) (Epoetin Zeta) Administered Subcutaneously For The Treatment Of Renal Anaemia (Pasco Ii) |
Actual Study Start Date : | July 2010 |
Estimated Primary Completion Date : | April 2022 |
Estimated Study Completion Date : | April 2022 |

Group/Cohort |
---|
Single group |
- Incidence Rate of Adverse Events of Special Interest [ Time Frame: 156 weeks ]Ongoing routine doctor visits for 156 weeks
- Adverse drug reactions [ Time Frame: 156 weeks ]Descriptive evaluation including incidence rates of adverse drug reactions.
- Information on treatment with Retacrit during pregnancy and lactation [ Time Frame: 156 weeks ]
- Data on long term use [ Time Frame: 156 weeks ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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™

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543477

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01543477 History of Changes |
Other Study ID Numbers: |
EPOE-09-11 C1111006 ( Other Identifier: Alias Study Number ) PASCO II ( Other Identifier: Alias Study Number ) |
First Posted: | March 5, 2012 Key Record Dates |
Last Update Posted: | March 15, 2018 |
Last Verified: | March 2018 |
Additional relevant MeSH terms:
Anemia Hematologic Diseases |