POST-AUTHORISATION SAFETY COHORT OBSERVATION OF RETACRIT (EPOETIN ZETA) ADMINISTERED SUBCUTANEOUSLY FOR THE TREATMENT OF RENAL ANAEMIA (PASCO II)

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

Sponsors

Lead sponsor: Pfizer

Collaborator: Hospira, now a wholly owned subsidiary of Pfizer

Source 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.

Overall Status Active, not recruiting
Start Date July 7, 2010
Completion Date April 30, 2022
Primary Completion Date April 30, 2022
Study Type Observational
Primary Outcome
Measure Time Frame
Incidence Rate of Adverse Events of Special Interest 156 weeks
Secondary Outcome
Measure Time Frame
Adverse drug reactions 156 weeks
Information on treatment with Retacrit during pregnancy and lactation 156 weeks
Data on long term use 156 weeks
Enrollment 4502
Condition
Eligibility

Sampling method: Non-Probability Sample

Criteria:

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™

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Location
facility
MHAT "Dr. Tota Venkova"AD | Gabrovo, 5300, Bulgaria
MHAT "Dr. Stamen Iliev"AD | Montana, 3400, Bulgaria
UMHAT "Georgi Stranski" EAD | Pleven, 5800, Bulgaria
MHAT Plovdiv AD | Plovdiv, 4000, Bulgaria
MHAT Plodiv AD | Plovdiv, 4003, Bulgaria
MHAT "Dr. Bratan Shukerov" AD | Smolian, 4700, Bulgaria
Fifth MHAT EAD | Sofia, 1233, Bulgaria
MHAT "Tokuda Hospital Sofia" | Sofia, 1407, Bulgaria
MC "Angio" OOD | Sofia, 1431, Bulgaria
UMHAT "Alexandrovska" EAD | Sofia, 1431, Bulgaria
SHATPD "Prof. Ivan Mitev"EAD | Sofia, 1606, Bulgaria
DCC "Sveta Anna" Sofia | Sofia, 1709, Bulgaria
MHAT "Sveta Marina" EAD | Varna, 9010, Bulgaria
UMHAT "Sveta Marina"EAD | Varna, 9010, Bulgaria
County Hospital Cakovec | Cakovec, 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 | Sibenik, 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
HUS Kirurginen sairaala | Helsinki, 00290, Finland
Pietarsaari Hospital Medical clinic | Jakobstad, 68601, Finland
Kainuu Hospital | Kajaani, 87140, Finland
CHU Amiens, service de Nefrologie | Amiens (Salouel), 80054, France
Hopital Sud | Amiens (Salouel), 80054, France
Centre Hospitalier de Cahors | Cahors Cedex 9, 46005, France
Aura Auvergne | Chamallieres, 63400, France
Hospital Gabriel Montpied | Clermont Ferrand, 63003, France
Centre Medico Chirurgical de l'Europe | Le Port Marly, 78560, France
Polyclinique de la LouvièreService Hemodialyse Nephrologie | Lille, 59000, France
Aura Notre Dame de Bon Securs | Paris Cedex 14, France
Aura | Paris, 75014, France
CHU Rangueil, Département de Néphrologie et Transplantation d'organes, Hypertension artérielle | Toulouse Cedex 9, 31 059, France
Nephrologische Gemeinschaftspraxis | Alsfeld, 36304, Germany
PHV Dialysezentrum Alsfeld | Alsfeld, 36304, Germany
Internistische Gemeinschaftspraxis Dialyse | 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 Grunewald | Berlin, 14193, Germany
Dialyse Centrum Darmstadt | Darmstadt, 64295, Germany
Diabetes und Nierenzentrum | Dormagen, 41540, Germany
KfH Nierenzentrum | Essen, 45136, Germany
Praxis für Nephrologie | Frankenthal, 67227, Germany
Nierenzentrum Heppenheim | Heppenheim, 64646, Germany
DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG | Herne, 44623, Germany
Dialyse Herzberg | 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 Marsen | Köln, 50937, Germany
Praxis Dres. Schönwald und Beck | Langenfeld, 40764, Germany
Nephrologische Praxis | Langenselbold, 63505, Germany
Nierenzentrum Leverkusen | Leverkusen, 51373, Germany
Dialysezentrum Ludwigslust | Ludwigslust, 19288, Germany
Nephrologische Gemeinschaftspraxis | Luebeck, 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
NDZ Viersen-Nettetal | Nettetal, 41334, Germany
ze:ro Dialysezentren und Gemeinschaftspraxis | Neustadt, 67433, Germany
Nephrologisches- und Dialysezentrum Niebüll | Niebüll, 25899, Germany
Klinikum Ernst von Bergmann | Porrsdam, 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 fur Diagnostik Department of Nephrology | Wiesbaden, 65191, Germany
General Hospital "Asklipeiio Voulas" | Voula, Attiki, 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 | Aigaleo, 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 | Filiates, 463 00, Greece
General Hospital of Grevena | Grevena, 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 | Kyparissia, 245 00, Greece
Private Physician | Lamia, 35100, Greece
General University Hospital of Larisa | Larisa, 413 34, Greece
General Clinic Eftichios Patsidis | Larisa, 41335, Greece
General Hospital of Mesologgi | Mesologgi, 30200, Greece
Private Physician | Nea Raidestos, Thessaloniki, 57001, Greece
General Hospital Agios Andreas | Patra, 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 | Veria, 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, 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
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
Azienda Ospedaliera S. Anna | Cona-Ferrara, 44124, Italy
AOU Careggi Hospital Firenze | Firenze, 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 | Milano, 20126, Italy
Universita degli Studi di Napoli Federico II - Dipartimento di Patologia Sistematica | Naples, 80131, Italy
A.O. MONALDI- Dept nephrology and Dialysis | Napoli, 80100, Italy
Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli" - U.O. S. C. Nefrologia ed Emodialisi | Napoli, 80131, Italy
Seconda Università degli Studi di Napoli, Nefrologia | Napoli, 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 | Benalmadena, Málaga, 29630, Spain
Hospital Lluis Alcanyis | Xativa, Valencia, 46800, Spain
Fundació Puigvert | Barcelona, 08025, Spain
Hospital de Barcelona | Barcelona, 08034, Spain
Hospital Universitario de Leon | Leon, 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
Danderyds hospital | Stockholm, 18288, Sweden
Kings College Hospital | London, SE5 9RS, United Kingdom
Location Countries

Bulgaria

Croatia

Denmark

Finland

France

Germany

Greece

Ireland

Italy

Spain

Sweden

United Kingdom

Verification Date

October 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Single group

Acronym PASCO II
Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov