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

NCT ID: NCT01543477

Last Updated: 2020-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4501 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-07

Study Completion Date

2020-04-29

Brief Summary

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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

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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.

Conditions

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Renal Anemia Pregnancy Lactation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single group

No interventions assigned to this group

Eligibility Criteria

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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™
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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MHAT "Dr. Tota Venkova"AD

Gabrovo, , Bulgaria

Site Status

MHAT "Dr. Stamen Iliev"AD

Montana, , Bulgaria

Site Status

UMHAT "Georgi Stranski" EAD

Pleven, , Bulgaria

Site Status

Dutchmed Dialysis Clinic (in the building of 5 DCC)

Plovdiv, , Bulgaria

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MHAT Plodiv AD

Plovdiv, , Bulgaria

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MHAT "Dr. Bratan Shukerov" AD

Smolyan, , Bulgaria

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Fifth MHAT EAD

Sofia, , Bulgaria

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Acibadem City Clinic Tokuda Hospital EAD MHAT "Tokuda Hospital Sofia"

Sofia, , Bulgaria

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University Hospital Lozenets

Sofia, , Bulgaria

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UMHAT "Alexandrovska" EAD

Sofia, , Bulgaria

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SHATPD "Prof. Ivan Mitev"EAD

Sofia, , Bulgaria

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DCC "Sveta Anna" Sofia

Sofia, , Bulgaria

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Kidney center - Medical center EOOD

Varna, , Bulgaria

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UMHAT "Sveta Marina"EAD

Varna, , Bulgaria

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County Hospital Cakovec

Čakovec, , Croatia

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General Hospital Dubrovnik

Dubrovnik, , Croatia

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General Hospital Karlovac

Karlovac, , Croatia

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Health Center Labin

Labin, , Croatia

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University Hospital Centre Osijek

Osijek, , Croatia

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General Hospital Sibenik

Šibenik, , Croatia

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Health Center Umag

Umag, , Croatia

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University Hospital Centre Zagreb

Zagreb, , Croatia

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University Hospital Merkur

Zagreb, , Croatia

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Department of Renal Medicine Medicinerhuset 3 sal Aalborg University Hospital

Aalborg, , Denmark

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Div. of Nephrology, Helsinki University HospitalHUS Kirurginen sairaala

Helsinki, , Finland

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Pietarsaari Hospital Medical clinic

Jakobstad, , Finland

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Kainuu Hospital

Kajaani, , Finland

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CHU Amiens-Picardie Site Sud,, service de Nefrologie

Amiens (Salouel) Cedex 1, , France

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CHU Amiens-Picardie Site Sud

Amiens (Salouel) Cedex 1, , France

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Centre Hospitalier de Cahors

Cahors, , France

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Aura Auvergne Chamalières

Chamalières, , France

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Hospital Gabriel Montpied, Centre de Dialyse

Clermont-Ferrand, , France

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35 Nephrologie Centre Medico Chirurgical de l'Europe

Le Port-Marly, , France

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Polyclinique de la Louvière, Service Hemodialyse Nephrologie CHSA Maubeuge

Lille, , France

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Aura Paris Plaisance

Paris, , France

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Aura Notre Dame de Bon Secours

Paris, , France

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Hopital de Rangueil, service de nephrologie

Toulouse, , France

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Nephrologische Gemeinschaftspraxis

Alsfeld, , Germany

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PHV Dialysezentrum Alsfeld

Alsfeld, , Germany

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MVZ DaVita Alzey GmbH

Alzey, , Germany

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Gemeinschaftspraxis Dr. Gööck & Dr. Anger

Arnstadt, , Germany

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MVZ Bad Bevensen

Bad Bevensen, , Germany

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Nephrologische Gemeinschaftspraxis

Bad Homburg, , Germany

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Nephrologsiche Praxis

Bad König, , Germany

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Internistische Praxis und Nephrologie

Bad Nauheim, , Germany

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Nieren-und Hochdruckzentrum

Bad Wildungen, , Germany

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Praxis F. Nierenkrankheiten/Tagesklinik

Berlin, , Germany

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Gesundheitszentrum HSH

Berlin, , Germany

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Alwall-Haus Dialysezentrum Berlin

Berlin, , Germany

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Dialyse am Kurfürstendamm

Berlin, , Germany

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Praxis Marsen

Cologne, , Germany

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Dialyse Centrum Darmstadt

Darmstadt, , Germany

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MVZ DaVita Dormagen GmbH

Dormagen, , Germany

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KfH Nierenzentrum

Essen, , Germany

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Praxis für Nephrologie

Frankenthal, , Germany

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Nierenzentrum Heppenheim

Heppenheim an der Bergstrasse, , Germany

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Praxisklinik-Dialysezentrum Herne DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG

Herne, , Germany

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DaVita Elsterland

Herzberg, , Germany

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Dialyse T. Menzer Homberg-Efze

Homberg (Efze), , Germany

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Nephrologische Gemeinschaftspraxis und Dialysezentrum

Hoyerswerda, , Germany

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Gemeinschaftspraxis Grahl und Johnen

Hürth-Hermülheim, , Germany

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Westpfalz-Klinikum Kaiserslautern

Kaiserslautern, , Germany

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Nieren- und Hochdruckzentrum Kiel

Kiel, , Germany

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Medizinisches Versorgungszentrum MVZ Diaverum Kleve GmbH

Kleve, , Germany

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Praxis Dres. Schoenwald und Beck

Langenfeld, , Germany

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Nephrologische Praxis

Langenselbold, , Germany

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Nierenzentrum Leverkusen

Leverkusen, , Germany

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Dialysezentrum Ludwigslust

Ludwigslust, , Germany

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Nephrologische Gemeinschaftspraxis

Lübeck, , Germany

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Märkische Kliniken GmbH Klinikum Lüdenscheid

Lüdenscheid, , Germany

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Dialysezentrum Stadtfeld

Magdeburg, , Germany

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Nephrologische Praxis

Mayen, , Germany

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Nephrologisches Zentrum

Mettmann, , Germany

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Nephrologische Gemeinschaftspraxis

Mühlhausen, , Germany

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MVZ DaVita Viersen GmbH

Nettetal, , Germany

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ze:ro Dialysezentren und Gemeinschaftspraxis

Neustadt, , Germany

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Nephrologisches- und Dialysezentrum Niebüll

Niebüll, , Germany

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Klinikum Ernst von Bergmann

Potsdam, , Germany

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Dialysezentrum

Quedlinburg, , Germany

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Gemeinschaftspraxis Schuerfeld Moeller Henrich

Saarlouis, , Germany

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Städtisches Klinikum Solingen Abt. Nephrologie - Innere Medizin

Solingen, , Germany

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Dialysezentrum Tangermünde

Tangermünde, , Germany

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Deutsche Klinik fuer Diagnostik Department of Nephrology

Wiesbaden, , Germany

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General Hospital "Asklipeiio Voulas"

Voula, Attica, Greece

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General Hospital of Rhodes

Agioi Apostoloi, , Greece

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General Hospital of Agios Nikolaos

Agios Nikolaos, Crete, , Greece

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Private Physician

Agrinio, , Greece

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Office of Eleni Stefanopoulou/Private Physician

Aigáleo, , Greece

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University General Hospital of Alexandroupoli

Alexandroupoli, , Greece

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Polikliniki Athinon

Athens, , Greece

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Therapeutical Department "ATTIKO"

Athens, , Greece

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General Hospital Gennimata

Athens, , Greece

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General Hospital "Alexandra"

Athens, , Greece

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Errikos Ntinan Hospital

Athens, , Greece

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Kyanos Stavros

Athens, , Greece

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Aretaiion Hospital

Athens, , Greece

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General University Hospital "ATTIKO"

Athens, , Greece

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General Hospital of Athens "A.Fleming"

Athens, , Greece

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Private Physician

Athens, , Greece

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General Hospital of Chania

Chania, Crete, , Greece

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Didimoticho General Hospital

Didimoticho, , Greece

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Drama General Hospital

Drama, , Greece

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Edessa General Hospital

Edessa, , Greece

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General Hospital of Filiates

Filiátes, , Greece

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General Hospital of Grevena

Grevená, , Greece

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Kavala General Hospital

Kavala, , Greece

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General Hospital of Komotini Sismanogleio

Komotini, , Greece

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Private Physician

Kozani, , Greece

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General Hospital of Kyparissia

Kyparissía, , Greece

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Private Physician

Lamia, , Greece

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General University Hospital of Larisa

Larissa, , Greece

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General Clinic Eftichios Patsidis

Larissa, , Greece

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General Hospital of Mesologgi

Mesologgi, , Greece

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Private Physician

Nea Raidestos, Thessaloniki, , Greece

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General Hospital Agios Andreas

Pátrai, , Greece

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General Hospital of Prolemaida

Ptolemaida, , Greece

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Serres general Hospital

Serres, , Greece

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AHEPA University Hospital

Thessaloniki, , Greece

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Ippokrateion General Hospital

Thessaloniki, , Greece

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Private Physician

Thessaloniki, , Greece

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Private Physician

Thessaloniki, , Greece

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Papageorgiou General Hospital

Thessaloniki, , Greece

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Private Physician

Thessaloniki, , Greece

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"Diavalkaniko" Therareutical Center

Thessaloniki, , Greece

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Therapeutical Department of Thermi

Thessaloniki, , Greece

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Papanikolaou General Hospital

Thessaloniki, , Greece

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Private Physician

Véria, , Greece

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Thessaliki Nosileutiki EPE

Volos, , Greece

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Private Physician

Voula, , Greece

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Private Physician

Voula, , Greece

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Merlin Park Dialysis Unit

Galway, , Ireland

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Presidio ospesdaliero G.CRISCUOLI - UO DIALISI

Sant'Angelo dei Lombardi, Avellino, Italy

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Policlinico S. Marco di Istituti Ospedalieri Bergamaschi, U.O. Nefrologia e Dialisi

Zingonia- Osio Sotto, Bergamo, Italy

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"Presidio Ospedaliero" di Soverato - Servizio Dialisi

Soverato Marina, Catanzaro, Italy

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Presidio Ospedaliero S. GIUSEPPE e MELORIO AUSL CE/2 S. - U.O. Nefrologia e Dialisi

Santa Maria Capua Vetere, CE, Italy

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Azienda Ospedaliera S. Anna

Cona-Ferrara, Ferrara, Italy

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U.O.C. Nefrologia e Dialisi Ospedale degli Infermi-S.Miniato-USL 11 Empoli

San Miniato, PISA, Italy

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U.O. Nefrologia e Dialisi, Azienda Ospedaliero-Universitaria Ospedali Riuniti

Ancona, , Italy

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Ospedali Riuniti Anzio-Nettuno, Nefrologia e Dialisi ASL RMH

Anzio (RM), , Italy

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Centro Dialisi Nefrologia - Ospedale S. Donato Arezzo

Arezzo, , Italy

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Dipartimento di Nefrologia- Ospedale Mazzoni

Ascoli Piceno, , Italy

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P.O. S.G. Moscati

Aversa (NA), , Italy

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OSPEDALE MAGGIORE DI CHIERI - ASL TO 5 - S.C. Nefrologia e Dialisi

Chieri (TO), , Italy

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AOU Careggi Hospital Firenze

Florence, , Italy

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Ospedale della Misericordia USL9

Grosseto, , Italy

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Dipartimento di Nefrologia Ospedale Versilia-Viareggio (Lucca)

Lido Di Camaiore (Lucca), , Italy

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U.O. Nefrologia Lucca

Lucca, , Italy

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U.O. Nefrologia e Dialisi ULSS12

Mestre, , Italy

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Ospedale Niguarda Cà Granda - U.O. Nefrologia e Dialisi e Terapia Medica del Trapianto Renale

Milan, , Italy

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Universita degli Studi di Napoli Federico II - Dipartimento di Patologia Sistematica

Naples, , Italy

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A.O. MONALDI- Dept nephrology and Dialysis

Napoli, , Italy

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Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli" - U.O. S. C. Nefrologia ed Emodialisi

Napoli, , Italy

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Azienda Ospedaliera Universitaria della Università degli Studi della Campania "Luigi Vanvitelli"

Napoli, , Italy

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ASL SA 1 P.O. Umberto I - U.O.C. di NEFROLOGIA E DIALISI

Nocera Inferiore (SA), , Italy

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Ospedale SANTA MARIA DELLA PIETA - U.O.C. di NEFROLOGIA E DIALISI

Nola (NA), , Italy

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Dipartimento di Medicina -DIMED- Policlinico Padova

Padua, , Italy

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Fondazione S. Maugeri - IRCCS Clinica del Lavoro e della Riabilitazione,

Pavia, , Italy

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UO Nefrologia, trapianti e dialisi SSN EDIFICIO 30A Azienda Ospedaliera Universitaria Pisa

PISA (Cisanello), , Italy

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U.O.C. Nefrologia e Dialisi - Ospedale "Del Ceppo"

Pistoia, , Italy

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U.O.C. Nefrologia e Dialisi Azienda Ospedaliera

San Sebastiano, , Italy

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U.O.C. Nefrologia, Dialisi e Trapianto - Azienda Ospedaliera Universitaria Senese

Siena, , Italy

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A.O.U. San Giovanni Battista di Torino - S.C. di Nefrologia, Dialisi e Trapianto

Torino, , Italy

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Ospedale Martini - S.C. Nefrologia E Dialisi

Torino, , Italy

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Ospedale San Giovanni Bosco - Struttura Complessa Nefrologia e Dialisi

Torino, , Italy

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Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

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Xanit Hospital Internacional

Benalmádena, Málaga, Spain

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Hospital Lluis Alcanyis

Xàtiva, Valencia, Spain

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Fundació Puigvert

Barcelona, , Spain

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Hospital de Barcelona

Barcelona, , Spain

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Hospital Universitario de Leon

León, , Spain

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Hospital central della Cruz Roja

Madrid, , Spain

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Hospital Universitario Central de Asturias

Oviedo, , Spain

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Hospital Parc Taulí

Sabadell, , Spain

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Hospital Virgen de la Concha

Zamora, , Spain

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Karlskoga Lasarett

Karlskoga, , Sweden

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Linköpings Universitetssjukhus

Linköping, , Sweden

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Karolinska University Hospital

Stockholm, , Sweden

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Njurmedicinska kliniken, Danderyds sjukhus

Stockholm, , Sweden

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Kings College Hospital

London, , United Kingdom

Site Status

Countries

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

Other Identifiers

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C1111006

Identifier Type: OTHER

Identifier Source: secondary_id

PASCO II

Identifier Type: OTHER

Identifier Source: secondary_id

EPOE-09-11

Identifier Type: -

Identifier Source: org_study_id

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