Pregnancy Clinical Trial
— PASCO IIOfficial title:
POST-AUTHORISATION SAFETY COHORT OBSERVATION OF RETACRIT (EPOETIN ZETA) ADMINISTERED SUBCUTANEOUSLY FOR THE TREATMENT OF RENAL ANAEMIA (PASCO II)
| Verified date | September 2020 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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™ |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer | Hospira, now a wholly owned subsidiary of Pfizer |
Bulgaria, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Spain, Sweden, United Kingdom,
| 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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