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)
3 other identifiers
observational
4,501
12 countries
179
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2010
Longer than P75 for all trials
179 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 7, 2010
CompletedFirst Submitted
Initial submission to the registry
February 21, 2012
CompletedFirst Posted
Study publicly available on registry
March 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2020
CompletedOctober 1, 2020
September 1, 2020
9.8 years
February 21, 2012
September 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence Rate of Adverse Events of Special Interest
Ongoing routine doctor visits for 156 weeks
156 weeks
Secondary Outcomes (3)
Adverse drug reactions
156 weeks
Information on treatment with Retacrit during pregnancy and lactation
156 weeks
Data on long term use
156 weeks
Study Arms (1)
Single group
Eligibility Criteria
Patients currently under treatment with Retacrit (epoetin zeta) administered subcutaneously for renal anaemia.
You may qualify if:
- 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
You may not qualify if:
- Any contraindications as per the current Summary of Product Characteristics (SPC) of Retacrit™
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Hospira, now a wholly owned subsidiary of Pfizercollaborator
Study Sites (179)
MHAT "Dr. Tota Venkova"AD
Gabrovo, 5300, Bulgaria
MHAT "Dr. Stamen Iliev"AD
Montana, 3400, Bulgaria
UMHAT "Georgi Stranski" EAD
Pleven, 5800, Bulgaria
Dutchmed Dialysis Clinic (in the building of 5 DCC)
Plovdiv, 4023, Bulgaria
MHAT Plodiv AD
Plovdiv, 4027, Bulgaria
MHAT "Dr. Bratan Shukerov" AD
Smolyan, 4700, Bulgaria
Fifth MHAT EAD
Sofia, 1233, Bulgaria
Acibadem City Clinic Tokuda Hospital EAD MHAT "Tokuda Hospital Sofia"
Sofia, 1407, Bulgaria
University Hospital Lozenets
Sofia, 1407, Bulgaria
UMHAT "Alexandrovska" EAD
Sofia, 1431, Bulgaria
SHATPD "Prof. Ivan Mitev"EAD
Sofia, 1606, Bulgaria
DCC "Sveta Anna" Sofia
Sofia, 1709, Bulgaria
Kidney center - Medical center EOOD
Varna, 9010, Bulgaria
UMHAT "Sveta Marina"EAD
Varna, 9010, Bulgaria
County Hospital Cakovec
Čakovec, 40000, Croatia
General Hospital Dubrovnik
Dubrovnik, 20000, Croatia
General Hospital Karlovac
Karlovac, 47000, Croatia
Health Center Labin
Labin, 52220, Croatia
University Hospital Centre Osijek
Osijek, 31000, Croatia
General Hospital Sibenik
Šibenik, 22000, Croatia
Health Center Umag
Umag, 52470, Croatia
University Hospital Centre Zagreb
Zagreb, 10000, Croatia
University Hospital Merkur
Zagreb, 10000, Croatia
Department of Renal Medicine Medicinerhuset 3 sal Aalborg University Hospital
Aalborg, 9100, Denmark
Div. of Nephrology, Helsinki University HospitalHUS Kirurginen sairaala
Helsinki, 00290, Finland
Pietarsaari Hospital Medical clinic
Jakobstad, 68601, Finland
Kainuu Hospital
Kajaani, 87140, Finland
CHU Amiens-Picardie Site Sud,, service de Nefrologie
Amiens (Salouel) Cedex 1, 80054, France
CHU Amiens-Picardie Site Sud
Amiens (Salouel) Cedex 1, 80054, France
Centre Hospitalier de Cahors
Cahors, 46005, France
Aura Auvergne Chamalières
Chamalières, 63400, France
Hospital Gabriel Montpied, Centre de Dialyse
Clermont-Ferrand, 63000, France
35 Nephrologie Centre Medico Chirurgical de l'Europe
Le Port-Marly, 78560, France
Polyclinique de la Louvière, Service Hemodialyse Nephrologie CHSA Maubeuge
Lille, 59800, France
Aura Paris Plaisance
Paris, 75014, France
Aura Notre Dame de Bon Secours
Paris, France
Hopital de Rangueil, service de nephrologie
Toulouse, 31059, France
Nephrologische Gemeinschaftspraxis
Alsfeld, 36304, Germany
PHV Dialysezentrum Alsfeld
Alsfeld, 36304, Germany
MVZ DaVita Alzey GmbH
Alzey, 55232, Germany
Gemeinschaftspraxis Dr. Gööck & Dr. Anger
Arnstadt, 99310, Germany
MVZ Bad Bevensen
Bad Bevensen, 29549, Germany
Nephrologische Gemeinschaftspraxis
Bad Homburg, 61352, Germany
Nephrologsiche Praxis
Bad König, 64732, Germany
Internistische Praxis und Nephrologie
Bad Nauheim, 61231, Germany
Nieren-und Hochdruckzentrum
Bad Wildungen, 34537, Germany
Praxis F. Nierenkrankheiten/Tagesklinik
Berlin, 12627, Germany
Gesundheitszentrum HSH
Berlin, 13051, Germany
Alwall-Haus Dialysezentrum Berlin
Berlin, 13125, Germany
Dialyse am Kurfürstendamm
Berlin, 14193, Germany
Praxis Marsen
Cologne, 50937, Germany
Dialyse Centrum Darmstadt
Darmstadt, 64295, Germany
MVZ DaVita Dormagen GmbH
Dormagen, 41540, Germany
KfH Nierenzentrum
Essen, 45136, Germany
Praxis für Nephrologie
Frankenthal, 67227, Germany
Nierenzentrum Heppenheim
Heppenheim an der Bergstrasse, 64646, Germany
Praxisklinik-Dialysezentrum Herne DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG
Herne, 44623, Germany
DaVita Elsterland
Herzberg, 04916, Germany
Dialyse T. Menzer Homberg-Efze
Homberg (Efze), 34576, Germany
Nephrologische Gemeinschaftspraxis und Dialysezentrum
Hoyerswerda, 02977, Germany
Gemeinschaftspraxis Grahl und Johnen
Hürth-Hermülheim, 50354, Germany
Westpfalz-Klinikum Kaiserslautern
Kaiserslautern, 67655, Germany
Nieren- und Hochdruckzentrum Kiel
Kiel, 24106, Germany
Medizinisches Versorgungszentrum MVZ Diaverum Kleve GmbH
Kleve, 47533, Germany
Praxis Dres. Schoenwald und Beck
Langenfeld, 40764, Germany
Nephrologische Praxis
Langenselbold, 63505, Germany
Nierenzentrum Leverkusen
Leverkusen, 51373, Germany
Dialysezentrum Ludwigslust
Ludwigslust, 19288, Germany
Nephrologische Gemeinschaftspraxis
Lübeck, 23562, Germany
Märkische Kliniken GmbH Klinikum Lüdenscheid
Lüdenscheid, 58515, Germany
Dialysezentrum Stadtfeld
Magdeburg, 39108, Germany
Nephrologische Praxis
Mayen, 56727, Germany
Nephrologisches Zentrum
Mettmann, 40822, Germany
Nephrologische Gemeinschaftspraxis
Mühlhausen, 99974, Germany
MVZ DaVita Viersen GmbH
Nettetal, 41334, Germany
ze:ro Dialysezentren und Gemeinschaftspraxis
Neustadt, 67433, Germany
Nephrologisches- und Dialysezentrum Niebüll
Niebüll, 25899, Germany
Klinikum Ernst von Bergmann
Potsdam, 14467, Germany
Dialysezentrum
Quedlinburg, 06484, Germany
Gemeinschaftspraxis Schuerfeld Moeller Henrich
Saarlouis, 66740, Germany
Städtisches Klinikum Solingen Abt. Nephrologie - Innere Medizin
Solingen, 42653, Germany
Dialysezentrum Tangermünde
Tangermünde, 39590, Germany
Deutsche Klinik fuer Diagnostik Department of Nephrology
Wiesbaden, 65191, Germany
General Hospital "Asklipeiio Voulas"
Voula, Attica, 166 73, Greece
General Hospital of Rhodes
Agioi Apostoloi, 851 00, Greece
General Hospital of Agios Nikolaos
Agios Nikolaos, Crete, 721 00, Greece
Private Physician
Agrinio, 30100, Greece
Office of Eleni Stefanopoulou/Private Physician
Aigáleo, 12243, Greece
University General Hospital of Alexandroupoli
Alexandroupoli, 681 00, Greece
Polikliniki Athinon
Athens, 10682, Greece
Therapeutical Department "ATTIKO"
Athens, 113 62, Greece
General Hospital Gennimata
Athens, 115 27, Greece
General Hospital "Alexandra"
Athens, 115 28, Greece
Errikos Ntinan Hospital
Athens, 11526, Greece
Kyanos Stavros
Athens, 11526, Greece
Aretaiion Hospital
Athens, 11528, Greece
General University Hospital "ATTIKO"
Athens, 124 62, Greece
General Hospital of Athens "A.Fleming"
Athens, 151 27, Greece
Private Physician
Athens, 15235, Greece
General Hospital of Chania
Chania, Crete, 733 00, Greece
Didimoticho General Hospital
Didimoticho, 683 00, Greece
Drama General Hospital
Drama, 661 00, Greece
Edessa General Hospital
Edessa, 582 00, Greece
General Hospital of Filiates
Filiátes, 463 00, Greece
General Hospital of Grevena
Grevená, 511 00, Greece
Kavala General Hospital
Kavala, 655 00, Greece
General Hospital of Komotini Sismanogleio
Komotini, 691 00, Greece
Private Physician
Kozani, 50100, Greece
General Hospital of Kyparissia
Kyparissía, 245 00, Greece
Private Physician
Lamia, 35100, Greece
General University Hospital of Larisa
Larissa, 413 34, Greece
General Clinic Eftichios Patsidis
Larissa, 41335, Greece
General Hospital of Mesologgi
Mesologgi, 30200, Greece
Private Physician
Nea Raidestos, Thessaloniki, 57001, Greece
General Hospital Agios Andreas
Pátrai, 26 335, Greece
General Hospital of Prolemaida
Ptolemaida, 502 00, Greece
Serres general Hospital
Serres, 621 00, Greece
AHEPA University Hospital
Thessaloniki, 546 36, Greece
Ippokrateion General Hospital
Thessaloniki, 546 39, Greece
Private Physician
Thessaloniki, 54642, Greece
Private Physician
Thessaloniki, 56224, Greece
Papageorgiou General Hospital
Thessaloniki, 564 29, Greece
Private Physician
Thessaloniki, 56431, Greece
"Diavalkaniko" Therareutical Center
Thessaloniki, 570 01, Greece
Therapeutical Department of Thermi
Thessaloniki, 570 01, Greece
Papanikolaou General Hospital
Thessaloniki, 570 10, Greece
Private Physician
Véria, 59100, Greece
Thessaliki Nosileutiki EPE
Volos, 38221, Greece
Private Physician
Voula, 166 75, Greece
Private Physician
Voula, 16673, Greece
Merlin Park Dialysis Unit
Galway, Ireland
Presidio ospesdaliero G.CRISCUOLI - UO DIALISI
Sant'Angelo dei Lombardi, Avellino, 83054, Italy
Policlinico S. Marco di Istituti Ospedalieri Bergamaschi, U.O. Nefrologia e Dialisi
Zingonia- Osio Sotto, Bergamo, 24040, Italy
"Presidio Ospedaliero" di Soverato - Servizio Dialisi
Soverato Marina, Catanzaro, 88068, Italy
Presidio Ospedaliero S. GIUSEPPE e MELORIO AUSL CE/2 S. - U.O. Nefrologia e Dialisi
Santa Maria Capua Vetere, CE, 81055, Italy
Azienda Ospedaliera S. Anna
Cona-Ferrara, Ferrara, 44124, Italy
U.O.C. Nefrologia e Dialisi Ospedale degli Infermi-S.Miniato-USL 11 Empoli
San Miniato, PISA, 56027, Italy
U.O. Nefrologia e Dialisi, Azienda Ospedaliero-Universitaria Ospedali Riuniti
Ancona, 60020, Italy
Ospedali Riuniti Anzio-Nettuno, Nefrologia e Dialisi ASL RMH
Anzio (RM), 00042, Italy
Centro Dialisi Nefrologia - Ospedale S. Donato Arezzo
Arezzo, 52100, Italy
Dipartimento di Nefrologia- Ospedale Mazzoni
Ascoli Piceno, 63100, Italy
P.O. S.G. Moscati
Aversa (NA), 80031, Italy
OSPEDALE MAGGIORE DI CHIERI - ASL TO 5 - S.C. Nefrologia e Dialisi
Chieri (TO), 10023, Italy
AOU Careggi Hospital Firenze
Florence, 50134, Italy
Ospedale della Misericordia USL9
Grosseto, 58100, Italy
Dipartimento di Nefrologia Ospedale Versilia-Viareggio (Lucca)
Lido Di Camaiore (Lucca), 55043, Italy
U.O. Nefrologia Lucca
Lucca, 55100, Italy
U.O. Nefrologia e Dialisi ULSS12
Mestre, 30174, Italy
Ospedale Niguarda Cà Granda - U.O. Nefrologia e Dialisi e Terapia Medica del Trapianto Renale
Milan, 20126, Italy
Universita degli Studi di Napoli Federico II - Dipartimento di Patologia Sistematica
Naples, 80131, Italy
A.O. MONALDI- Dept nephrology and Dialysis
Napoli, 80100, Italy
Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli" - U.O. S. C. Nefrologia ed Emodialisi
Napoli, 80131, Italy
Azienda Ospedaliera Universitaria della Università degli Studi della Campania "Luigi Vanvitelli"
Napoli, 80131, Italy
ASL SA 1 P.O. Umberto I - U.O.C. di NEFROLOGIA E DIALISI
Nocera Inferiore (SA), 84014, Italy
Ospedale SANTA MARIA DELLA PIETA - U.O.C. di NEFROLOGIA E DIALISI
Nola (NA), 80035, Italy
Dipartimento di Medicina -DIMED- Policlinico Padova
Padua, 35128, Italy
Fondazione S. Maugeri - IRCCS Clinica del Lavoro e della Riabilitazione,
Pavia, 27100, Italy
UO Nefrologia, trapianti e dialisi SSN EDIFICIO 30A Azienda Ospedaliera Universitaria Pisa
PISA (Cisanello), 56124, Italy
U.O.C. Nefrologia e Dialisi - Ospedale "Del Ceppo"
Pistoia, 51100, Italy
U.O.C. Nefrologia e Dialisi Azienda Ospedaliera
San Sebastiano, 81100, Italy
U.O.C. Nefrologia, Dialisi e Trapianto - Azienda Ospedaliera Universitaria Senese
Siena, 53100, Italy
A.O.U. San Giovanni Battista di Torino - S.C. di Nefrologia, Dialisi e Trapianto
Torino, 10126, Italy
Ospedale Martini - S.C. Nefrologia E Dialisi
Torino, 10141, Italy
Ospedale San Giovanni Bosco - Struttura Complessa Nefrologia e Dialisi
Torino, 10154, Italy
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
Xanit Hospital Internacional
Benalmádena, Málaga, 29630, Spain
Hospital Lluis Alcanyis
Xàtiva, Valencia, 46800, Spain
Fundació Puigvert
Barcelona, 08025, Spain
Hospital de Barcelona
Barcelona, 08034, Spain
Hospital Universitario de Leon
León, 24071, Spain
Hospital central della Cruz Roja
Madrid, 28003, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Hospital Parc Taulí
Sabadell, 08208, Spain
Hospital Virgen de la Concha
Zamora, 49022, Spain
Karlskoga Lasarett
Karlskoga, 69181, Sweden
Linköpings Universitetssjukhus
Linköping, 58185, Sweden
Karolinska University Hospital
Stockholm, 14186, Sweden
Njurmedicinska kliniken, Danderyds sjukhus
Stockholm, 18288, Sweden
Kings College Hospital
London, SE5 9RS, United Kingdom
Biospecimen
Pre-dose serum samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2012
First Posted
March 5, 2012
Study Start
July 7, 2010
Primary Completion
April 29, 2020
Study Completion
April 29, 2020
Last Updated
October 1, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share
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.