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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Lactation; Renal Anemia

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 Type: Observational
• Enrollment (Actual): 4501

Contacts and Locations

Study Locations

• Bulgaria
  • Gabrovo, Bulgaria, 5300
    • MHAT "Dr. Tota Venkova"AD
  • Montana, Bulgaria, 3400
    • MHAT "Dr. Stamen Iliev"AD
  • Pleven, Bulgaria, 5800
    • UMHAT "Georgi Stranski" EAD
  • Plovdiv, Bulgaria, 4023
    • Dutchmed Dialysis Clinic (in the building of 5 DCC)
  • Plovdiv, Bulgaria, 4027
    • MHAT Plodiv AD
  • Smolian, Bulgaria, 4700
    • MHAT "Dr. Bratan Shukerov" AD
  • Sofia, Bulgaria, 1431
    • UMHAT "Alexandrovska" EAD
  • Sofia, Bulgaria, 1233
    • Fifth MHAT EAD
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Tokuda Hospital EAD MHAT "Tokuda Hospital Sofia"
  • Sofia, Bulgaria, 1407
    • University Hospital Lozenets
  • Sofia, Bulgaria, 1606
    • SHATPD "Prof. Ivan Mitev"EAD
  • Sofia, Bulgaria, 1709
    • DCC "Sveta Anna" Sofia
  • Varna, Bulgaria, 9010
    • Kidney center - Medical center EOOD
  • Varna, Bulgaria, 9010
    • UMHAT "Sveta Marina"EAD
• Croatia
  • Cakovec, Croatia, 40000
    • County Hospital Cakovec
  • Dubrovnik, Croatia, 20000
    • General Hospital Dubrovnik
  • Karlovac, Croatia, 47000
    • General Hospital Karlovac
  • Labin, Croatia, 52220
    • Health Center Labin
  • Osijek, Croatia, 31000
    • University Hospital Centre Osijek
  • Sibenik, Croatia, 22000
    • General Hospital Sibenik
  • Umag, Croatia, 52470
    • Health Center Umag
  • Zagreb, Croatia, 10000
    • University Hospital Merkur
  • Zagreb, Croatia, 10000
    • University Hospital Centre Zagreb
• Denmark
  • Aalborg, Denmark, 9100
    • Department of Renal Medicine Medicinerhuset 3 sal Aalborg University Hospital
• Finland
  • Helsinki, Finland, 00290
    • Div. of Nephrology, Helsinki University HospitalHUS Kirurginen sairaala
  • Jakobstad, Finland, 68601
    • Pietarsaari Hospital Medical clinic
  • Kajaani, Finland, 87140
    • Kainuu Hospital
• France
  • Amiens (Salouel) Cedex 1, France, 80054
    • CHU Amiens-Picardie Site Sud,, service de Nefrologie
  • Amiens (Salouel) Cedex 1, France, 80054
    • CHU Amiens-Picardie Site Sud
  • Cahors Cedex 9, France, 46005
    • Centre Hospitalier de Cahors
  • Chamalieres, France, 63400
    • Aura Auvergne Chamalières
  • Clermont Ferrand, France, 63000
    • Hospital Gabriel Montpied, Centre de Dialyse
  • Le Port Marly, France, 78560
    • 35 Nephrologie Centre Medico Chirurgical de l'Europe
  • Lille, France, 59800
    • Polyclinique de la Louvière, Service Hemodialyse Nephrologie CHSA Maubeuge
  • Paris, France, 75014
    • AURA Paris Plaisance
  • Paris Cedex 14, France
    • Aura Notre Dame de Bon Secours
  • Toulouse Cedex 9, France, 31059
    • Hopital de Rangueil, service de nephrologie
• Germany
  • Alsfeld, Germany, 36304
    • Nephrologische Gemeinschaftspraxis
  • Alsfeld, Germany, 36304
    • PHV Dialysezentrum Alsfeld
  • Alzey, Germany, 55232
    • MVZ DaVita Alzey GmbH
  • Arnstadt, Germany, 99310
    • Gemeinschaftspraxis Dr. Gööck & Dr. Anger
  • Bad Bevensen, Germany, 29549
    • MVZ Bad Bevensen
  • Bad Homburg, Germany, 61352
    • Nephrologische Gemeinschaftspraxis
  • Bad König, Germany, 64732
    • Nephrologsiche Praxis
  • Bad Nauheim, Germany, 61231
    • Internistische Praxis und Nephrologie
  • Bad Wildungen, Germany, 34537
    • Nieren-und Hochdruckzentrum
  • Berlin, Germany, 12627
    • Praxis F. Nierenkrankheiten/Tagesklinik
  • Berlin, Germany, 13051
    • Gesundheitszentrum HSH
  • Berlin, Germany, 13125
    • Alwall-Haus Dialysezentrum Berlin
  • Berlin, Germany, 14193
    • Dialyse am Kurfürstendamm
  • Darmstadt, Germany, 64295
    • Dialyse Centrum Darmstadt
  • Dormagen, Germany, 41540
    • MVZ DaVita Dormagen GmbH
  • Essen, Germany, 45136
    • KfH Nierenzentrum
  • Frankenthal, Germany, 67227
    • Praxis für Nephrologie
  • Heppenheim, Germany, 64646
    • Nierenzentrum Heppenheim
  • Herne, Germany, 44623
    • Praxisklinik-Dialysezentrum Herne DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG
  • Herzberg, Germany, 04916
    • DaVita Elsterland
  • Homberg/Efze, Germany, 34576
    • Dialyse T. Menzer Homberg-Efze
  • Hoyerswerda, Germany, 02977
    • Nephrologische Gemeinschaftspraxis und Dialysezentrum
  • Hürth-Hermülheim, Germany, 50354
    • Gemeinschaftspraxis Grahl und Johnen
  • Kaiserslautern, Germany, 67655
    • Westpfalz-Klinikum Kaiserslautern
  • Kiel, Germany, 24106
    • Nieren- und Hochdruckzentrum Kiel
  • Kleve, Germany, 47533
    • Medizinisches Versorgungszentrum MVZ Diaverum Kleve GmbH
  • Köln, Germany, 50937
    • Praxis Marsen
  • Langenfeld, Germany, 40764
    • Praxis Dres. Schoenwald und Beck
  • Langenselbold, Germany, 63505
    • Nephrologische Praxis
  • Leverkusen, Germany, 51373
    • Nierenzentrum Leverkusen
  • Ludwigslust, Germany, 19288
    • Dialysezentrum Ludwigslust
  • Luebeck, Germany, 23562
    • Nephrologische Gemeinschaftspraxis
  • Lüdenscheid, Germany, 58515
    • Märkische Kliniken GmbH Klinikum Lüdenscheid
  • Magdeburg, Germany, 39108
    • Dialysezentrum Stadtfeld
  • Mayen, Germany, 56727
    • Nephrologische Praxis
  • Mettmann, Germany, 40822
    • Nephrologisches Zentrum
  • Mühlhausen, Germany, 99974
    • Nephrologische Gemeinschaftspraxis
  • Nettetal, Germany, 41334
    • MVZ DaVita Viersen GmbH
  • Neustadt, Germany, 67433
    • ze:ro Dialysezentren und Gemeinschaftspraxis
  • Niebüll, Germany, 25899
    • Nephrologisches- und Dialysezentrum Niebüll
  • Potsdam, Germany, 14467
    • Klinikum Ernst von Bergmann
  • Quedlinburg, Germany, 06484
    • Dialysezentrum
  • Saarlouis, Germany, 66740
    • Gemeinschaftspraxis Schuerfeld Moeller Henrich
  • Solingen, Germany, 42653
    • Städtisches Klinikum Solingen Abt. Nephrologie - Innere Medizin
  • Tangermünde, Germany, 39590
    • Dialysezentrum Tangermünde
  • Wiesbaden, Germany, 65191
    • Deutsche Klinik fuer Diagnostik Department of Nephrology
• Greece
  • Agioi Apostoloi, Greece, 851 00
    • General Hospital of Rhodes
  • Agios Nikolaos, Crete, Greece, 721 00
    • General Hospital of Agios Nikolaos
  • Agrinio, Greece, 30100
    • Private physician
  • Aigaleo, Greece, 12243
    • Office of Eleni Stefanopoulou/Private Physician
  • Alexandroupoli, Greece, 681 00
    • University General Hospital of Alexandroupoli
  • Athens, Greece, 10682
    • Polikliniki Athinon
  • Athens, Greece, 113 62
    • Therapeutical Department "ATTIKO"
  • Athens, Greece, 115 27
    • General Hospital Gennimata
  • Athens, Greece, 115 28
    • General Hospital "Alexandra"
  • Athens, Greece, 11526
    • Errikos Ntinan Hospital
  • Athens, Greece, 11526
    • Kyanos Stavros
  • Athens, Greece, 11528
    • Aretaiion Hospital
  • Athens, Greece, 124 62
    • General University Hospital "ATTIKO"
  • Athens, Greece, 151 27
    • General Hospital of Athens "A.Fleming"
  • Athens, Greece, 15235
    • Private physician
  • Chania, Crete, Greece, 733 00
    • General Hospital of Chania
  • Didimoticho, Greece, 683 00
    • Didimoticho General Hospital
  • Drama, Greece, 661 00
    • Drama General Hospital
  • Edessa, Greece, 582 00
    • Edessa General Hospital
  • Filiates, Greece, 463 00
    • General Hospital of Filiates
  • Grevena, Greece, 511 00
    • General Hospital of Grevena
  • Kavala, Greece, 655 00
    • Kavala General Hospital
  • Komotini, Greece, 691 00
    • General Hospital of Komotini Sismanogleio
  • Kozani, Greece, 50100
    • Private physician
  • Kyparissia, Greece, 245 00
    • General Hospital of Kyparissia
  • Lamia, Greece, 35100
    • Private physician
  • Larisa, Greece, 413 34
    • General University Hospital of Larisa
  • Larisa, Greece, 41335
    • General Clinic Eftichios Patsidis
  • Mesologgi, Greece, 30200
    • General Hospital of Mesologgi
  • Nea Raidestos, Thessaloniki, Greece, 57001
    • Private physician
  • Patra, Greece, 26 335
    • General Hospital Agios Andreas
  • Ptolemaida, Greece, 502 00
    • General Hospital of Prolemaida
  • Serres, Greece, 621 00
    • Serres general Hospital
  • Thessaloniki, Greece, 564 29
    • Papageorgiou General Hospital
  • Thessaloniki, Greece, 546 36
    • Ahepa University Hospital
  • Thessaloniki, Greece, 546 39
    • Ippokrateion General Hospital
  • Thessaloniki, Greece, 54642
    • Private physician
  • Thessaloniki, Greece, 56224
    • Private physician
  • Thessaloniki, Greece, 56431
    • Private physician
  • Thessaloniki, Greece, 570 01
    • "Diavalkaniko" Therareutical Center
  • Thessaloniki, Greece, 570 01
    • Therapeutical Department of Thermi
  • Thessaloniki, Greece, 570 10
    • Papanikolaou General Hospital
  • Veria, Greece, 59100
    • Private physician
  • Volos, Greece, 38221
    • Thessaliki Nosileutiki EPE
  • Voula, Greece, 166 75
    • Private physician
  • Voula, Greece, 16673
    • Private physician
  • Attiki
    • Voula, Attiki, Greece, 166 73
      • General Hospital "Asklipeiio Voulas"
• Ireland
  • Galway, Ireland
    • Merlin Park Dialysis Unit
• Italy
  • Ancona, Italy, 60020
    • U.O. Nefrologia e Dialisi, Azienda Ospedaliero-Universitaria Ospedali Riuniti
  • Anzio (RM), Italy, 00042
    • Ospedali Riuniti Anzio-Nettuno, Nefrologia e Dialisi ASL RMH
  • Arezzo, Italy, 52100
    • Centro Dialisi Nefrologia - Ospedale S. Donato Arezzo
  • Ascoli Piceno, Italy, 63100
    • Dipartimento di Nefrologia- Ospedale Mazzoni
  • Aversa (NA), Italy, 80031
    • P.O. S.G. Moscati
  • Chieri (TO), Italy, 10023
    • OSPEDALE MAGGIORE DI CHIERI - ASL TO 5 - S.C. Nefrologia e Dialisi
  • Firenze, Italy, 50134
    • AOU Careggi Hospital Firenze
  • Grosseto, Italy, 58100
    • Ospedale della Misericordia USL9
  • Lido Di Camaiore (Lucca), Italy, 55043
    • Dipartimento di Nefrologia Ospedale Versilia-Viareggio (Lucca)
  • Lucca, Italy, 55100
    • U.O. Nefrologia Lucca
  • Mestre, Italy, 30174
    • U.O. Nefrologia e Dialisi ULSS12
  • Milano, Italy, 20126
    • Ospedale Niguarda Cà Granda - U.O. Nefrologia e Dialisi e Terapia Medica del Trapianto Renale
  • Naples, Italy, 80131
    • Universita degli Studi di Napoli Federico II - Dipartimento di Patologia Sistematica
  • Napoli, Italy, 80100
    • A.O. MONALDI- Dept nephrology and Dialysis
  • Napoli, Italy, 80131
    • Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli" - U.O. S. C. Nefrologia ed Emodialisi
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria della Università degli Studi della Campania "Luigi Vanvitelli"
  • Nocera Inferiore (SA), Italy, 84014
    • ASL SA 1 P.O. Umberto I - U.O.C. di NEFROLOGIA E DIALISI
  • Nola (NA), Italy, 80035
    • Ospedale SANTA MARIA DELLA PIETA - U.O.C. di NEFROLOGIA E DIALISI
  • PISA (Cisanello), Italy, 56124
    • UO Nefrologia, trapianti e dialisi SSN EDIFICIO 30A Azienda Ospedaliera Universitaria Pisa
  • Padova, Italy, 35128
    • Dipartimento di Medicina -DIMED- Policlinico Padova
  • Pavia, Italy, 27100
    • Fondazione S. Maugeri - IRCCS Clinica del Lavoro e della Riabilitazione,
  • Pistoia, Italy, 51100
    • U.O.C. Nefrologia e Dialisi - Ospedale "Del Ceppo"
  • San Sebastiano, Italy, 81100
    • U.O.C. Nefrologia e Dialisi Azienda Ospedaliera
  • Siena, Italy, 53100
    • U.O.C. Nefrologia, Dialisi e Trapianto - Azienda Ospedaliera Universitaria Senese
  • Torino, Italy, 10126
    • A.O.U. San Giovanni Battista di Torino - S.C. di Nefrologia, Dialisi e Trapianto
  • Torino, Italy, 10141
    • Ospedale Martini - S.C. Nefrologia E Dialisi
  • Torino, Italy, 10154
    • Ospedale San Giovanni Bosco - Struttura Complessa Nefrologia e Dialisi
  • Avellino
    • Sant'Angelo dei Lombardi, Avellino, Italy, 83054
      • Presidio ospesdaliero G.CRISCUOLI - UO DIALISI
  • Bergamo
    • Zingonia- Osio Sotto, Bergamo, Italy, 24040
      • Policlinico S. Marco di Istituti Ospedalieri Bergamaschi, U.O. Nefrologia e Dialisi
  • CE
    • Santa Maria Capua Vetere, CE, Italy, 81055
      • Presidio Ospedaliero S. GIUSEPPE e MELORIO AUSL CE/2 S. - U.O. Nefrologia e Dialisi
  • Catanzaro
    • Soverato, Catanzaro, Italy, 88068
      • "Presidio Ospedaliero" di Soverato - Servizio Dialisi
  • Ferrara
    • Cona-Ferrara, Ferrara, Italy, 44124
      • Azienda Ospedaliera S. Anna
  • Pisa
    • San Miniato, Pisa, Italy, 56027
      • U.O.C. Nefrologia e Dialisi Ospedale degli Infermi-S.Miniato-USL 11 Empoli
• Spain
  • Barcelona, Spain, 08025
    • Fundacio Puigvert
  • Barcelona, Spain, 08034
    • Hospital de Barcelona
  • Leon, Spain, 24071
    • Hospital Universitario de Leon
  • Madrid, Spain, 28003
    • Hospital central della Cruz Roja
  • Oviedo, Spain, 33011
    • Hospital Universitario Central de Asturias
  • Sabadell, Spain, 08208
    • Hospital Parc Tauli
  • Zamora, Spain, 49022
    • Hospital Virgen de la Concha
  • Madrid
    • Fuenlabrada, Madrid, Spain, 28942
      • Hospital Universitario de Fuenlabrada
  • Málaga
    • Benalmadena, Málaga, Spain, 29630
      • Xanit Hospital Internacional
  • Valencia
    • Xativa, Valencia, Spain, 46800
      • Hospital Lluis Alcanyis
• Sweden
  • Karlskoga, Sweden, 69181
    • Karlskoga Lasarett
  • Linköping, Sweden, 58185
    • Linkopings Universitetssjukhus
  • Stockholm, Sweden, 14186
    • Karolinska University Hospital
  • Stockholm, Sweden, 18288
    • Njurmedicinska kliniken, Danderyds sjukhus
• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients currently under treatment with Retacrit (epoetin zeta) administered subcutaneously for renal anaemia.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Single group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence Rate of Adverse Events of Special Interest	Ongoing routine doctor visits for 156 weeks	156 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Hospira, now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2010
• Primary Completion (Actual): April 29, 2020
• Study Completion (Actual): April 29, 2020

Study Registration Dates

• First Submitted: February 21, 2012
• First Submitted That Met QC Criteria: February 27, 2012
• First Posted (Estimate): March 5, 2012

Study Record Updates

• Last Update Posted (Actual): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: EPOE-09-11; C1111006 (Other Identifier: Alias Study Number); PASCO II (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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/data_requests.