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| ID | Type | Description | Link |
|---|---|---|---|
| C1111006 | Other Identifier | Alias Study Number | |
| PASCO II | Other Identifier | Alias Study Number |
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| Name | Class |
|---|---|
| Hospira, now a wholly owned subsidiary of Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single group |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Adverse Events of Special Interest | Ongoing routine doctor visits for 156 weeks | 156 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients currently under treatment with Retacrit (epoetin zeta) administered subcutaneously for renal anaemia.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MHAT "Dr. Tota Venkova"AD | Gabrovo | 5300 | Bulgaria | |||
| MHAT "Dr. Stamen Iliev"AD |
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.
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Pre-dose serum samples
| Data on long term use | 156 weeks |
| 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 |
| A.O. MONALDI- Dept nephrology and Dialysis | Naples | 80100 | Italy |
| Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli" - U.O. S. C. Nefrologia ed Emodialisi | Naples | 80131 | Italy |
| Azienda Ospedaliera Universitaria della Università degli Studi della Campania "Luigi Vanvitelli" | Naples | 80131 | Italy |
| Universita degli Studi di Napoli Federico II - Dipartimento di Patologia Sistematica | Naples | 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 | Padova | 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 |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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