Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia
- Conditions
- Renal AnemiaPregnancyLactation
- Registration Number
- NCT01543477
- Lead Sponsor
- Pfizer
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4501
- 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
- Any contraindications as per the current Summary of Product Characteristics (SPC) of Retacrit™
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence Rate of Adverse Events of Special Interest 156 weeks Ongoing routine doctor visits for 156 weeks
- Secondary Outcome Measures
Name Time Method Data on long term use 156 weeks Adverse drug reactions 156 weeks Descriptive evaluation including incidence rates of adverse drug reactions.
Information on treatment with Retacrit during pregnancy and lactation 156 weeks
Trial Locations
- Locations (165)
Pietarsaari Hospital Medical clinic
🇫🇮Jakobstad, Finland
Department of Renal Medicine Medicinerhuset 3 sal Aalborg University Hospital
🇩🇰Aalborg, Denmark
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
Fifth MHAT EAD
🇧🇬Sofia, Bulgaria
Kainuu Hospital
🇫🇮Kajaani, Finland
Acibadem City Clinic Tokuda Hospital EAD MHAT "Tokuda Hospital Sofia"
🇧🇬Sofia, Bulgaria
University Hospital Lozenets
🇧🇬Sofia, Bulgaria
UMHAT "Alexandrovska" EAD
🇧🇬Sofia, Bulgaria
SHATPD "Prof. Ivan Mitev"EAD
🇧🇬Sofia, Bulgaria
DCC "Sveta Anna" Sofia
🇧🇬Sofia, Bulgaria
County Hospital Cakovec
🇭🇷Cakovec, Croatia
University Hospital Merkur
🇭🇷Zagreb, Croatia
Kidney center - Medical center EOOD
🇧🇬Varna, Bulgaria
General Hospital Dubrovnik
🇭🇷Dubrovnik, Croatia
General Hospital Karlovac
🇭🇷Karlovac, Croatia
UMHAT "Sveta Marina"EAD
🇧🇬Varna, Bulgaria
Health Center Labin
🇭🇷Labin, Croatia
University Hospital Centre Osijek
🇭🇷Osijek, Croatia
Health Center Umag
🇭🇷Umag, Croatia
Div. of Nephrology, Helsinki University HospitalHUS Kirurginen sairaala
🇫🇮Helsinki, Finland
CHU Amiens-Picardie Site Sud,, service de Nefrologie
🇫🇷Amiens (Salouel) Cedex 1, France
General Hospital Sibenik
🇭🇷Sibenik, Croatia
University Hospital Centre Zagreb
🇭🇷Zagreb, Croatia
CHU Amiens-Picardie Site Sud
🇫🇷Amiens (Salouel) Cedex 1, France
Hospital Gabriel Montpied, Centre de Dialyse
🇫🇷Clermont Ferrand, France
Gemeinschaftspraxis Dr. Gööck & Dr. Anger
🇩🇪Arnstadt, Germany
Centre Hospitalier de Cahors
🇫🇷Cahors Cedex 9, France
Aura Auvergne Chamalières
🇫🇷Chamalieres, France
Polyclinique de la Louvière, Service Hemodialyse Nephrologie CHSA Maubeuge
🇫🇷Lille, France
MVZ Bad Bevensen
🇩🇪Bad Bevensen, Germany
Nephrologsiche Praxis
🇩🇪Bad König, Germany
Alwall-Haus Dialysezentrum Berlin
🇩🇪Berlin, Germany
35 Nephrologie Centre Medico Chirurgical de l'Europe
🇫🇷Le Port Marly, France
PHV Dialysezentrum Alsfeld
🇩🇪Alsfeld, Germany
Aura Notre Dame de Bon Secours
🇫🇷Paris Cedex 14, France
Internistische Praxis und Nephrologie
🇩🇪Bad Nauheim, Germany
Dialyse Centrum Darmstadt
🇩🇪Darmstadt, Germany
Hopital de Rangueil, service de nephrologie
🇫🇷Toulouse Cedex 9, France
Nephrologische Gemeinschaftspraxis
🇩🇪Mühlhausen, Germany
Nieren-und Hochdruckzentrum
🇩🇪Bad Wildungen, Germany
Praxis für Nephrologie
🇩🇪Frankenthal, Germany
Dialyse T. Menzer Homberg-Efze
🇩🇪Homberg/Efze, Germany
Aura Paris Plaisance
🇫🇷Paris, France
MVZ DaVita Alzey GmbH
🇩🇪Alzey, Germany
Märkische Kliniken GmbH Klinikum Lüdenscheid
🇩🇪Lüdenscheid, Germany
Praxis F. Nierenkrankheiten/Tagesklinik
🇩🇪Berlin, Germany
KfH Nierenzentrum
🇩🇪Essen, Germany
Nierenzentrum Heppenheim
🇩🇪Heppenheim, Germany
Westpfalz-Klinikum Kaiserslautern
🇩🇪Kaiserslautern, Germany
Nieren- und Hochdruckzentrum Kiel
🇩🇪Kiel, Germany
Praxis Dres. Schoenwald und Beck
🇩🇪Langenfeld, Germany
Nierenzentrum Leverkusen
🇩🇪Leverkusen, Germany
Dialysezentrum Ludwigslust
🇩🇪Ludwigslust, Germany
Gesundheitszentrum HSH
🇩🇪Berlin, Germany
MVZ DaVita Dormagen GmbH
🇩🇪Dormagen, Germany
Praxisklinik-Dialysezentrum Herne DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG
🇩🇪Herne, Germany
Dialyse am Kurfürstendamm
🇩🇪Berlin, Germany
DaVita Elsterland
🇩🇪Herzberg, Germany
Gemeinschaftspraxis Grahl und Johnen
🇩🇪Hürth-Hermülheim, Germany
Medizinisches Versorgungszentrum MVZ Diaverum Kleve GmbH
🇩🇪Kleve, Germany
Nephrologische Gemeinschaftspraxis und Dialysezentrum
🇩🇪Hoyerswerda, Germany
Nephrologische Praxis
🇩🇪Mayen, Germany
Dialysezentrum Stadtfeld
🇩🇪Magdeburg, Germany
Nephrologisches Zentrum
🇩🇪Mettmann, Germany
University General Hospital of Alexandroupoli
🇬🇷Alexandroupoli, Greece
Praxis Marsen
🇩🇪Köln, 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
Deutsche Klinik fuer Diagnostik Department of Nephrology
🇩🇪Wiesbaden, Germany
General Hospital of Agios Nikolaos
🇬🇷Agios Nikolaos, Crete, Greece
Office of Eleni Stefanopoulou/Private Physician
🇬🇷Aigaleo, Greece
Aretaiion Hospital
🇬🇷Athens, Greece
General Hospital of Chania
🇬🇷Chania, Crete, Greece
Didimoticho General Hospital
🇬🇷Didimoticho, Greece
General Hospital of Grevena
🇬🇷Grevena, Greece
General Hospital of Mesologgi
🇬🇷Mesologgi, Greece
Serres general Hospital
🇬🇷Serres, Greece
AHEPA University Hospital
🇬🇷Thessaloniki, Greece
Gemeinschaftspraxis Schuerfeld Moeller Henrich
🇩🇪Saarlouis, Germany
General Hospital of Rhodes
🇬🇷Agioi Apostoloi, Greece
Städtisches Klinikum Solingen Abt. Nephrologie - Innere Medizin
🇩🇪Solingen, Germany
Dialysezentrum Tangermünde
🇩🇪Tangermünde, Germany
General Hospital "Asklipeiio Voulas"
🇬🇷Voula, Attiki, Greece
General Hospital Gennimata
🇬🇷Athens, Greece
General Hospital "Alexandra"
🇬🇷Athens, Greece
Errikos Ntinan Hospital
🇬🇷Athens, Greece
General University Hospital "ATTIKO"
🇬🇷Athens, Greece
Private Physician
🇬🇷Voula, Greece
Polikliniki Athinon
🇬🇷Athens, Greece
General Clinic Eftichios Patsidis
🇬🇷Larisa, Greece
Therapeutical Department "ATTIKO"
🇬🇷Athens, Greece
General Hospital of Athens "A.Fleming"
🇬🇷Athens, Greece
Drama General Hospital
🇬🇷Drama, Greece
General Hospital of Filiates
🇬🇷Filiates, Greece
Kyanos Stavros
🇬🇷Athens, Greece
Edessa General Hospital
🇬🇷Edessa, Greece
General University Hospital of Larisa
🇬🇷Larisa, Greece
Kavala General Hospital
🇬🇷Kavala, Greece
General Hospital of Komotini Sismanogleio
🇬🇷Komotini, Greece
General Hospital Agios Andreas
🇬🇷Patra, Greece
General Hospital of Prolemaida
🇬🇷Ptolemaida, Greece
General Hospital of Kyparissia
🇬🇷Kyparissia, Greece
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
AOU Careggi Hospital Firenze
🇮🇹Firenze, Italy
Ippokrateion General Hospital
🇬🇷Thessaloniki, Greece
Papageorgiou General Hospital
🇬🇷Thessaloniki, Greece
"Diavalkaniko" Therareutical Center
🇬🇷Thessaloniki, Greece
Therapeutical Department of Thermi
🇬🇷Thessaloniki, Greece
Papanikolaou General Hospital
🇬🇷Thessaloniki, Greece
Thessaliki Nosileutiki EPE
🇬🇷Volos, Greece
Merlin Park Dialysis Unit
🇮🇪Galway, Ireland
Presidio ospesdaliero G.CRISCUOLI - UO DIALISI
🇮🇹Sant'Angelo dei Lombardi, Avellino, Italy
Policlinico S. Marco di Istituti Ospedalieri Bergamaschi, U.O. Nefrologia e Dialisi
🇮🇹Zingonia- Osio Sotto, Bergamo, Italy
"Presidio Ospedaliero" di Soverato - Servizio Dialisi
🇮🇹Soverato, Catanzaro, Italy
Presidio Ospedaliero S. GIUSEPPE e MELORIO AUSL CE/2 S. - U.O. Nefrologia e Dialisi
🇮🇹Santa Maria Capua Vetere, CE, Italy
Azienda Ospedaliera S. Anna
🇮🇹Cona-Ferrara, Ferrara, Italy
U.O.C. Nefrologia e Dialisi Ospedale degli Infermi-S.Miniato-USL 11 Empoli
🇮🇹San Miniato, Pisa, 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
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
Fondazione S. Maugeri - IRCCS Clinica del Lavoro e della Riabilitazione,
🇮🇹Pavia, Italy
Dipartimento di Medicina -DIMED- Policlinico Padova
🇮🇹Padova, 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 Azienda Ospedaliera
🇮🇹San Sebastiano, Italy
U.O.C. Nefrologia, Dialisi e Trapianto - Azienda Ospedaliera Universitaria Senese
🇮🇹Siena, Italy
Hospital Parc Taulí
🇪🇸Sabadell, Spain
Karlskoga Lasarett
🇸🇪Karlskoga, Sweden
Njurmedicinska kliniken, Danderyds sjukhus
🇸🇪Stockholm, Sweden
Hospital de Barcelona
🇪🇸Barcelona, Spain
A.O.U. San Giovanni Battista di Torino - S.C. di Nefrologia, Dialisi e Trapianto
🇮🇹Torino, Italy
Linköpings Universitetssjukhus
🇸🇪Linköping, Sweden
Fundació Puigvert
🇪🇸Barcelona, Spain
Ospedale Martini - S.C. Nefrologia E Dialisi
🇮🇹Torino, Italy
Ospedale San Giovanni Bosco - Struttura Complessa Nefrologia e Dialisi
🇮🇹Torino, Italy
Xanit Hospital Internacional
🇪🇸Benalmadena, Málaga, Spain
Hospital Universitario de Fuenlabrada
🇪🇸Fuenlabrada, Madrid, Spain
Hospital Universitario de Leon
🇪🇸Leon, Spain
Hospital Lluis Alcanyis
🇪🇸Xativa, Valencia, Spain
Hospital central della Cruz Roja
🇪🇸Madrid, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Virgen de la Concha
🇪🇸Zamora, Spain
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Kings College Hospital
🇬🇧London, United Kingdom