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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01543477
Other study ID # EPOE-09-11
Secondary ID C1111006PASCO II
Status Completed
Phase
First received
Last updated
Start date July 7, 2010
Est. completion date April 29, 2020

Study information

Verified date September 2020
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4501
Est. completion date April 29, 2020
Est. primary completion date April 29, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Bulgaria 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 Acibadem City Clinic Tokuda Hospital EAD MHAT "Tokuda Hospital Sofia" Sofia
Bulgaria DCC "Sveta Anna" Sofia Sofia
Bulgaria Fifth MHAT EAD Sofia
Bulgaria SHATPD "Prof. Ivan Mitev"EAD Sofia
Bulgaria UMHAT "Alexandrovska" EAD Sofia
Bulgaria University Hospital Lozenets Sofia
Bulgaria Kidney center - Medical center EOOD Varna
Bulgaria UMHAT "Sveta Marina"EAD Varna
Croatia County Hospital Cakovec Cakovec
Croatia General Hospital Dubrovnik Dubrovnik
Croatia General Hospital Karlovac Karlovac
Croatia Health Center Labin Labin
Croatia University Hospital Centre Osijek Osijek
Croatia General Hospital Sibenik Sibenik
Croatia Health Center Umag Umag
Croatia University Hospital Centre Zagreb Zagreb
Croatia University Hospital Merkur Zagreb
Denmark Department of Renal Medicine Medicinerhuset 3 sal Aalborg University Hospital Aalborg
Finland Div. of Nephrology, Helsinki University HospitalHUS Kirurginen sairaala Helsinki
Finland Pietarsaari Hospital Medical clinic Jakobstad
Finland Kainuu Hospital Kajaani
France CHU Amiens-Picardie Site Sud Amiens (Salouel) Cedex 1
France CHU Amiens-Picardie Site Sud,, service de Nefrologie Amiens (Salouel) Cedex 1
France Centre Hospitalier de Cahors Cahors Cedex 9
France Aura Auvergne Chamalières Chamalieres
France Hospital Gabriel Montpied, Centre de Dialyse Clermont Ferrand
France 35 Nephrologie Centre Medico Chirurgical de l'Europe Le Port Marly
France Polyclinique de la Louvière, Service Hemodialyse Nephrologie CHSA Maubeuge Lille
France Aura Paris Plaisance Paris
France Aura Notre Dame de Bon Secours Paris Cedex 14
France Hopital de Rangueil, service de nephrologie Toulouse Cedex 9
Germany Nephrologische Gemeinschaftspraxis Alsfeld
Germany PHV Dialysezentrum Alsfeld Alsfeld
Germany MVZ DaVita Alzey GmbH Alzey
Germany Gemeinschaftspraxis Dr. Gööck & Dr. Anger Arnstadt
Germany MVZ Bad Bevensen Bad Bevensen
Germany Nephrologische Gemeinschaftspraxis Bad Homburg
Germany Nephrologsiche Praxis Bad König
Germany Internistische Praxis und Nephrologie Bad Nauheim
Germany Nieren-und Hochdruckzentrum Bad Wildungen
Germany Alwall-Haus Dialysezentrum Berlin Berlin
Germany Dialyse am Kurfürstendamm Berlin
Germany Gesundheitszentrum HSH Berlin
Germany Praxis F. Nierenkrankheiten/Tagesklinik Berlin
Germany Dialyse Centrum Darmstadt Darmstadt
Germany MVZ DaVita Dormagen GmbH Dormagen
Germany KfH Nierenzentrum Essen
Germany Praxis für Nephrologie Frankenthal
Germany Nierenzentrum Heppenheim Heppenheim
Germany Praxisklinik-Dialysezentrum Herne DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG Herne
Germany DaVita Elsterland Herzberg
Germany Dialyse T. Menzer Homberg-Efze Homberg/Efze
Germany Nephrologische Gemeinschaftspraxis und Dialysezentrum Hoyerswerda
Germany Gemeinschaftspraxis Grahl und Johnen Hürth-Hermülheim
Germany Westpfalz-Klinikum Kaiserslautern Kaiserslautern
Germany Nieren- und Hochdruckzentrum Kiel Kiel
Germany Medizinisches Versorgungszentrum MVZ Diaverum Kleve GmbH Kleve
Germany Praxis Marsen Köln
Germany Praxis Dres. Schoenwald und Beck Langenfeld
Germany Nephrologische Praxis Langenselbold
Germany Nierenzentrum Leverkusen Leverkusen
Germany Märkische Kliniken GmbH Klinikum Lüdenscheid Lüdenscheid
Germany Dialysezentrum Ludwigslust Ludwigslust
Germany Nephrologische Gemeinschaftspraxis Luebeck
Germany Dialysezentrum Stadtfeld Magdeburg
Germany Nephrologische Praxis Mayen
Germany Nephrologisches Zentrum Mettmann
Germany Nephrologische Gemeinschaftspraxis Mühlhausen
Germany MVZ DaVita Viersen GmbH Nettetal
Germany ze:ro Dialysezentren und Gemeinschaftspraxis Neustadt
Germany Nephrologisches- und Dialysezentrum Niebüll Niebüll
Germany Klinikum Ernst von Bergmann Potsdam
Germany Dialysezentrum Quedlinburg
Germany Gemeinschaftspraxis Schuerfeld Moeller Henrich Saarlouis
Germany Städtisches Klinikum Solingen Abt. Nephrologie - Innere Medizin Solingen
Germany Dialysezentrum Tangermünde Tangermünde
Germany Deutsche Klinik fuer Diagnostik Department of Nephrology Wiesbaden
Greece General Hospital of Rhodes Agioi Apostoloi
Greece General Hospital of Agios Nikolaos Agios Nikolaos, Crete
Greece Private Physician Agrinio
Greece Office of Eleni Stefanopoulou/Private Physician Aigaleo
Greece University General Hospital of Alexandroupoli Alexandroupoli
Greece Aretaiion Hospital Athens
Greece Errikos Ntinan Hospital Athens
Greece General Hospital "Alexandra" Athens
Greece General Hospital Gennimata Athens
Greece General Hospital of Athens "A.Fleming" Athens
Greece General University Hospital "ATTIKO" Athens
Greece Kyanos Stavros Athens
Greece Polikliniki Athinon Athens
Greece Private Physician Athens
Greece Therapeutical Department "ATTIKO" Athens
Greece General Hospital of Chania Chania, Crete
Greece Didimoticho General Hospital Didimoticho
Greece Drama General Hospital Drama
Greece Edessa General Hospital Edessa
Greece General Hospital of Filiates Filiates
Greece General Hospital of Grevena Grevena
Greece Kavala General Hospital Kavala
Greece General Hospital of Komotini Sismanogleio Komotini
Greece Private Physician Kozani
Greece General Hospital of Kyparissia Kyparissia
Greece Private Physician Lamia
Greece General Clinic Eftichios Patsidis Larisa
Greece General University Hospital of Larisa Larisa
Greece General Hospital of Mesologgi Mesologgi
Greece Private Physician Nea Raidestos, Thessaloniki
Greece General Hospital Agios Andreas Patra
Greece General Hospital of Prolemaida Ptolemaida
Greece Serres general Hospital Serres
Greece "Diavalkaniko" Therareutical Center Thessaloniki
Greece AHEPA University Hospital Thessaloniki
Greece Ippokrateion General Hospital Thessaloniki
Greece Papageorgiou General Hospital Thessaloniki
Greece Papanikolaou General Hospital Thessaloniki
Greece Private Physician Thessaloniki
Greece Private Physician Thessaloniki
Greece Private Physician Thessaloniki
Greece Therapeutical Department of Thermi Thessaloniki
Greece Private Physician Veria
Greece Thessaliki Nosileutiki EPE Volos
Greece General Hospital "Asklipeiio Voulas" Voula Attiki
Greece Private Physician Voula
Greece Private Physician Voula
Ireland Merlin Park Dialysis Unit Galway
Italy U.O. Nefrologia e Dialisi, Azienda Ospedaliero-Universitaria Ospedali Riuniti Ancona
Italy Ospedali Riuniti Anzio-Nettuno, Nefrologia e Dialisi ASL RMH Anzio (RM)
Italy Centro Dialisi Nefrologia - Ospedale S. Donato Arezzo Arezzo
Italy Dipartimento di Nefrologia- Ospedale Mazzoni Ascoli Piceno
Italy P.O. S.G. Moscati Aversa (NA)
Italy OSPEDALE MAGGIORE DI CHIERI - ASL TO 5 - S.C. Nefrologia e Dialisi Chieri (TO)
Italy Azienda Ospedaliera S. Anna Cona-Ferrara Ferrara
Italy AOU Careggi Hospital Firenze Firenze
Italy Ospedale della Misericordia USL9 Grosseto
Italy Dipartimento di Nefrologia Ospedale Versilia-Viareggio (Lucca) Lido Di Camaiore (Lucca)
Italy U.O. Nefrologia Lucca Lucca
Italy U.O. Nefrologia e Dialisi ULSS12 Mestre
Italy Ospedale Niguarda Cà Granda - U.O. Nefrologia e Dialisi e Terapia Medica del Trapianto Renale Milano
Italy Universita degli Studi di Napoli Federico II - Dipartimento di Patologia Sistematica Naples
Italy A.O. MONALDI- Dept nephrology and Dialysis Napoli
Italy Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli" - U.O. S. C. Nefrologia ed Emodialisi Napoli
Italy Azienda Ospedaliera Universitaria della Università degli Studi della Campania "Luigi Vanvitelli" Napoli
Italy ASL SA 1 P.O. Umberto I - U.O.C. di NEFROLOGIA E DIALISI Nocera Inferiore (SA)
Italy Ospedale SANTA MARIA DELLA PIETA - U.O.C. di NEFROLOGIA E DIALISI Nola (NA)
Italy Dipartimento di Medicina -DIMED- Policlinico Padova Padova
Italy Fondazione S. Maugeri - IRCCS Clinica del Lavoro e della Riabilitazione, Pavia
Italy UO Nefrologia, trapianti e dialisi SSN EDIFICIO 30A Azienda Ospedaliera Universitaria Pisa PISA (Cisanello)
Italy U.O.C. Nefrologia e Dialisi - Ospedale "Del Ceppo" Pistoia
Italy U.O.C. Nefrologia e Dialisi Ospedale degli Infermi-S.Miniato-USL 11 Empoli San Miniato Pisa
Italy U.O.C. Nefrologia e Dialisi Azienda Ospedaliera San Sebastiano
Italy Presidio ospesdaliero G.CRISCUOLI - UO DIALISI Sant'Angelo dei Lombardi Avellino
Italy Presidio Ospedaliero S. GIUSEPPE e MELORIO AUSL CE/2 S. - U.O. Nefrologia e Dialisi Santa Maria Capua Vetere CE
Italy U.O.C. Nefrologia, Dialisi e Trapianto - Azienda Ospedaliera Universitaria Senese Siena
Italy "Presidio Ospedaliero" di Soverato - Servizio Dialisi Soverato Catanzaro
Italy A.O.U. San Giovanni Battista di Torino - S.C. di Nefrologia, Dialisi e Trapianto Torino
Italy Ospedale Martini - S.C. Nefrologia E Dialisi Torino
Italy Ospedale San Giovanni Bosco - Struttura Complessa Nefrologia e Dialisi Torino
Italy Policlinico S. Marco di Istituti Ospedalieri Bergamaschi, U.O. Nefrologia e Dialisi Zingonia- Osio Sotto Bergamo
Spain Fundació Puigvert Barcelona
Spain Hospital de Barcelona Barcelona
Spain Xanit Hospital Internacional Benalmadena Málaga
Spain Hospital Universitario de Fuenlabrada Fuenlabrada Madrid
Spain Hospital Universitario de Leon Leon
Spain Hospital central della Cruz Roja Madrid
Spain Hospital Universitario Central de Asturias Oviedo
Spain Hospital Parc Taulí Sabadell
Spain Hospital Lluis Alcanyis Xativa Valencia
Spain Hospital Virgen de la Concha Zamora
Sweden Karlskoga Lasarett Karlskoga
Sweden Linköpings Universitetssjukhus Linköping
Sweden Karolinska University Hospital Stockholm
Sweden Njurmedicinska kliniken, Danderyds sjukhus Stockholm
United Kingdom Kings College Hospital London

Sponsors (2)

Lead Sponsor Collaborator
Pfizer Hospira, now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Bulgaria,  Croatia,  Denmark,  Finland,  France,  Germany,  Greece,  Ireland,  Italy,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence Rate of Adverse Events of Special Interest Ongoing routine doctor visits for 156 weeks 156 weeks
Secondary Adverse drug reactions Descriptive evaluation including incidence rates of adverse drug reactions. 156 weeks
Secondary Information on treatment with Retacrit during pregnancy and lactation 156 weeks
Secondary Data on long term use 156 weeks
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