Clinical trial NCT01543477: Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia
Official title: POST-AUTHORISATION SAFETY COHORT OBSERVATION OF RETACRIT (EPOETIN ZETA) ADMINISTERED SUBCUTANEOUSLY FOR THE TREATMENT OF RENAL ANAEMIA (PASCO II)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Anemia
Pregnancy
Lactation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2012-03-05
Enrollment: 4501
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients currently under treatment with Retacrit (epoetin zeta) administered subcutaneously for renal anaemia.

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.

Eligibility 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™

Primary outcomes:
measure: Incidence Rate of Adverse Events of Special Interest
timeFrame: 156 weeks
Secondary outcomes:
measure: Adverse drug reactions
timeFrame: 156 weeks
measure: Information on treatment with Retacrit during pregnancy and lactation
timeFrame: 156 weeks
measure: Data on long term use
timeFrame: 156 weeks
Other outcomes:
Locations:
city: Gabrovo
country: Bulgaria
facility: MHAT "Dr. Tota Venkova"AD
city: Montana
country: Bulgaria
facility: MHAT "Dr. Stamen Iliev"AD
city: Pleven
country: Bulgaria
facility: UMHAT "Georgi Stranski" EAD
city: Plovdiv
country: Bulgaria
facility: Dutchmed Dialysis Clinic (in the building of 5 DCC)
city: Plovdiv
country: Bulgaria
facility: MHAT Plodiv AD
city: Smolian
country: Bulgaria
facility: MHAT "Dr. Bratan Shukerov" AD
city: Sofia
country: Bulgaria
facility: Fifth MHAT EAD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Hospital EAD MHAT "Tokuda Hospital Sofia"
city: Sofia
country: Bulgaria
facility: University Hospital Lozenets
city: Sofia
country: Bulgaria
facility: UMHAT "Alexandrovska" EAD
city: Sofia
country: Bulgaria
facility: SHATPD "Prof. Ivan Mitev"EAD
city: Sofia
country: Bulgaria
facility: DCC "Sveta Anna" Sofia
city: Varna
country: Bulgaria
facility: Kidney center - Medical center EOOD
city: Varna
country: Bulgaria
facility: UMHAT "Sveta Marina"EAD
city: Cakovec
country: Croatia
facility: County Hospital Cakovec
city: Dubrovnik
country: Croatia
facility: General Hospital Dubrovnik
city: Karlovac
country: Croatia
facility: General Hospital Karlovac
city: Labin
country: Croatia
facility: Health Center Labin
city: Osijek
country: Croatia
facility: University Hospital Centre Osijek
city: Sibenik
country: Croatia
facility: General Hospital Sibenik
city: Umag
country: Croatia
facility: Health Center Umag
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
city: Zagreb
country: Croatia
facility: University Hospital Merkur
city: Aalborg
country: Denmark
facility: Department of Renal Medicine Medicinerhuset 3 sal Aalborg University Hospital
city: Helsinki
country: Finland
facility: Div. of Nephrology, Helsinki University HospitalHUS Kirurginen sairaala
city: Jakobstad
country: Finland
facility: Pietarsaari Hospital Medical clinic
city: Kajaani
country: Finland
facility: Kainuu Hospital
city: Amiens (Salouel) Cedex 1
country: France
facility: CHU Amiens-Picardie Site Sud,, service de Nefrologie
city: Amiens (Salouel) Cedex 1
country: France
facility: CHU Amiens-Picardie Site Sud
city: Cahors Cedex 9
country: France
facility: Centre Hospitalier de Cahors
city: Chamalieres
country: France
facility: Aura Auvergne Chamalières
city: Clermont Ferrand
country: France
facility: Hospital Gabriel Montpied, Centre de Dialyse
city: Le Port Marly
country: France
facility: 35 Nephrologie Centre Medico Chirurgical de l'Europe
city: Lille
country: France
facility: Polyclinique de la Louvière, Service Hemodialyse Nephrologie CHSA Maubeuge
city: Paris Cedex 14
country: France
facility: Aura Notre Dame de Bon Secours
city: Paris
country: France
facility: Aura Paris Plaisance
city: Toulouse Cedex 9
country: France
facility: Hopital de Rangueil, service de nephrologie
city: Alsfeld
country: Germany
facility: Nephrologische Gemeinschaftspraxis
city: Alsfeld
country: Germany
facility: PHV Dialysezentrum Alsfeld
city: Alzey
country: Germany
facility: MVZ DaVita Alzey GmbH
city: Arnstadt
country: Germany
facility: Gemeinschaftspraxis Dr. Gööck & Dr. Anger
city: Bad Bevensen
country: Germany
facility: MVZ Bad Bevensen
city: Bad Homburg
country: Germany
facility: Nephrologische Gemeinschaftspraxis
city: Bad König
country: Germany
facility: Nephrologsiche Praxis
city: Bad Nauheim
country: Germany
facility: Internistische Praxis und Nephrologie
city: Bad Wildungen
country: Germany
facility: Nieren-und Hochdruckzentrum
city: Berlin
country: Germany
facility: Praxis F. Nierenkrankheiten/Tagesklinik
city: Berlin
country: Germany
facility: Gesundheitszentrum HSH
city: Berlin
country: Germany
facility: Alwall-Haus Dialysezentrum Berlin
city: Berlin
country: Germany
facility: Dialyse am Kurfürstendamm
city: Darmstadt
country: Germany
facility: Dialyse Centrum Darmstadt
city: Dormagen
country: Germany
facility: MVZ DaVita Dormagen GmbH
city: Essen
country: Germany
facility: KfH Nierenzentrum
city: Frankenthal
country: Germany
facility: Praxis für Nephrologie
city: Heppenheim
country: Germany
facility: Nierenzentrum Heppenheim
city: Herne
country: Germany
facility: Praxisklinik-Dialysezentrum Herne DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG
city: Herzberg
country: Germany
facility: DaVita Elsterland
city: Homberg/Efze
country: Germany
facility: Dialyse T. Menzer Homberg-Efze
city: Hoyerswerda
country: Germany
facility: Nephrologische Gemeinschaftspraxis und Dialysezentrum
city: Hürth-Hermülheim
country: Germany
facility: Gemeinschaftspraxis Grahl und Johnen
city: Kaiserslautern
country: Germany
facility: Westpfalz-Klinikum Kaiserslautern
city: Kiel
country: Germany
facility: Nieren- und Hochdruckzentrum Kiel
city: Kleve
country: Germany
facility: Medizinisches Versorgungszentrum MVZ Diaverum Kleve GmbH
city: Köln
country: Germany
facility: Praxis Marsen
city: Langenfeld
country: Germany
facility: Praxis Dres. Schoenwald und Beck
city: Langenselbold
country: Germany
facility: Nephrologische Praxis
city: Leverkusen
country: Germany
facility: Nierenzentrum Leverkusen
city: Ludwigslust
country: Germany
facility: Dialysezentrum Ludwigslust
city: Luebeck
country: Germany
facility: Nephrologische Gemeinschaftspraxis
city: Lüdenscheid
country: Germany
facility: Märkische Kliniken GmbH Klinikum Lüdenscheid
city: Magdeburg
country: Germany
facility: Dialysezentrum Stadtfeld
city: Mayen
country: Germany
facility: Nephrologische Praxis
city: Mettmann
country: Germany
facility: Nephrologisches Zentrum
city: Mühlhausen
country: Germany
facility: Nephrologische Gemeinschaftspraxis
city: Nettetal
country: Germany
facility: MVZ DaVita Viersen GmbH
city: Neustadt
country: Germany
facility: ze:ro Dialysezentren und Gemeinschaftspraxis
city: Niebüll
country: Germany
facility: Nephrologisches- und Dialysezentrum Niebüll
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann
city: Quedlinburg
country: Germany
facility: Dialysezentrum
city: Saarlouis
country: Germany
facility: Gemeinschaftspraxis Schuerfeld Moeller Henrich
city: Solingen
country: Germany
facility: Städtisches Klinikum Solingen Abt. Nephrologie - Innere Medizin
city: Tangermünde
country: Germany
facility: Dialysezentrum Tangermünde
city: Wiesbaden
country: Germany
facility: Deutsche Klinik fuer Diagnostik Department of Nephrology
city: Voula
country: Greece
facility: General Hospital "Asklipeiio Voulas"
state: Attiki
city: Agioi Apostoloi
country: Greece
facility: General Hospital of Rhodes
city: Agios Nikolaos, Crete
country: Greece
facility: General Hospital of Agios Nikolaos
city: Agrinio
country: Greece
facility: Private Physician
city: Aigaleo
country: Greece
facility: Office of Eleni Stefanopoulou/Private Physician
city: Alexandroupoli
country: Greece
facility: University General Hospital of Alexandroupoli
city: Athens
country: Greece
facility: Polikliniki Athinon
city: Athens
country: Greece
facility: Therapeutical Department "ATTIKO"
city: Athens
country: Greece
facility: General Hospital Gennimata
city: Athens
country: Greece
facility: General Hospital "Alexandra"
city: Athens
country: Greece
facility: Errikos Ntinan Hospital
city: Athens
country: Greece
facility: Kyanos Stavros
city: Athens
country: Greece
facility: Aretaiion Hospital
city: Athens
country: Greece
facility: General University Hospital "ATTIKO"
city: Athens
country: Greece
facility: General Hospital of Athens "A.Fleming"
city: Athens
country: Greece
facility: Private Physician
city: Chania, Crete
country: Greece
facility: General Hospital of Chania
city: Didimoticho
country: Greece
facility: Didimoticho General Hospital
city: Drama
country: Greece
facility: Drama General Hospital
city: Edessa
country: Greece
facility: Edessa General Hospital
city: Filiates
country: Greece
facility: General Hospital of Filiates
city: Grevena
country: Greece
facility: General Hospital of Grevena
city: Kavala
country: Greece
facility: Kavala General Hospital
city: Komotini
country: Greece
facility: General Hospital of Komotini Sismanogleio
city: Kozani
country: Greece
facility: Private Physician
city: Kyparissia
country: Greece
facility: General Hospital of Kyparissia
city: Lamia
country: Greece
facility: Private Physician
city: Larisa
country: Greece
facility: General University Hospital of Larisa
city: Larisa
country: Greece
facility: General Clinic Eftichios Patsidis
city: Mesologgi
country: Greece
facility: General Hospital of Mesologgi
city: Nea Raidestos, Thessaloniki
country: Greece
facility: Private Physician
city: Patra
country: Greece
facility: General Hospital Agios Andreas
city: Ptolemaida
country: Greece
facility: General Hospital of Prolemaida
city: Serres
country: Greece
facility: Serres general Hospital
city: Thessaloniki
country: Greece
facility: AHEPA University Hospital
city: Thessaloniki
country: Greece
facility: Ippokrateion General Hospital
city: Thessaloniki
country: Greece
facility: Private Physician
city: Thessaloniki
country: Greece
facility: Private Physician
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital
city: Thessaloniki
country: Greece
facility: Private Physician
city: Thessaloniki
country: Greece
facility: "Diavalkaniko" Therareutical Center
city: Thessaloniki
country: Greece
facility: Therapeutical Department of Thermi
city: Thessaloniki
country: Greece
facility: Papanikolaou General Hospital
city: Veria
country: Greece
facility: Private Physician
city: Volos
country: Greece
facility: Thessaliki Nosileutiki EPE
city: Voula
country: Greece
facility: Private Physician
city: Voula
country: Greece
facility: Private Physician
city: Galway
country: Ireland
facility: Merlin Park Dialysis Unit
city: Sant'Angelo dei Lombardi
country: Italy
facility: Presidio ospesdaliero G.CRISCUOLI - UO DIALISI
state: Avellino
city: Zingonia- Osio Sotto
country: Italy
facility: Policlinico S. Marco di Istituti Ospedalieri Bergamaschi, U.O. Nefrologia e Dialisi
state: Bergamo
city: Soverato
country: Italy
facility: "Presidio Ospedaliero" di Soverato - Servizio Dialisi
state: Catanzaro
city: Santa Maria Capua Vetere
country: Italy
facility: Presidio Ospedaliero S. GIUSEPPE e MELORIO AUSL CE/2 S. - U.O. Nefrologia e Dialisi
state: CE
city: Cona-Ferrara
country: Italy
facility: Azienda Ospedaliera S. Anna
state: Ferrara
city: San Miniato
country: Italy
facility: U.O.C. Nefrologia e Dialisi Ospedale degli Infermi-S.Miniato-USL 11 Empoli
state: Pisa
city: Ancona
country: Italy
facility: U.O. Nefrologia e Dialisi, Azienda Ospedaliero-Universitaria Ospedali Riuniti
city: Anzio (RM)
country: Italy
facility: Ospedali Riuniti Anzio-Nettuno, Nefrologia e Dialisi ASL RMH
city: Arezzo
country: Italy
facility: Centro Dialisi Nefrologia - Ospedale S. Donato Arezzo
city: Ascoli Piceno
country: Italy
facility: Dipartimento di Nefrologia- Ospedale Mazzoni
city: Aversa (NA)
country: Italy
facility: P.O. S.G. Moscati
city: Chieri (TO)
country: Italy
facility: OSPEDALE MAGGIORE DI CHIERI - ASL TO 5 - S.C. Nefrologia e Dialisi
city: Firenze
country: Italy
facility: AOU Careggi Hospital Firenze
city: Grosseto
country: Italy
facility: Ospedale della Misericordia USL9
city: Lido Di Camaiore (Lucca)
country: Italy
facility: Dipartimento di Nefrologia Ospedale Versilia-Viareggio (Lucca)
city: Lucca
country: Italy
facility: U.O. Nefrologia Lucca
city: Mestre
country: Italy
facility: U.O. Nefrologia e Dialisi ULSS12
city: Milano
country: Italy
facility: Ospedale Niguarda Cà Granda - U.O. Nefrologia e Dialisi e Terapia Medica del Trapianto Renale
city: Naples
country: Italy
facility: Universita degli Studi di Napoli Federico II - Dipartimento di Patologia Sistematica
city: Napoli
country: Italy
facility: A.O. MONALDI- Dept nephrology and Dialysis
city: Napoli
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli" - U.O. S. C. Nefrologia ed Emodialisi
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria della Università degli Studi della Campania "Luigi Vanvitelli"
city: Nocera Inferiore (SA)
country: Italy
facility: ASL SA 1 P.O. Umberto I - U.O.C. di NEFROLOGIA E DIALISI
city: Nola (NA)
country: Italy
facility: Ospedale SANTA MARIA DELLA PIETA - U.O.C. di NEFROLOGIA E DIALISI
city: Padova
country: Italy
facility: Dipartimento di Medicina -DIMED- Policlinico Padova
city: Pavia
country: Italy
facility: Fondazione S. Maugeri - IRCCS Clinica del Lavoro e della Riabilitazione,
city: PISA (Cisanello)
country: Italy
facility: UO Nefrologia, trapianti e dialisi SSN EDIFICIO 30A Azienda Ospedaliera Universitaria Pisa
city: Pistoia
country: Italy
facility: U.O.C. Nefrologia e Dialisi - Ospedale "Del Ceppo"
city: San Sebastiano
country: Italy
facility: U.O.C. Nefrologia e Dialisi Azienda Ospedaliera
city: Siena
country: Italy
facility: U.O.C. Nefrologia, Dialisi e Trapianto - Azienda Ospedaliera Universitaria Senese
city: Torino
country: Italy
facility: A.O.U. San Giovanni Battista di Torino - S.C. di Nefrologia, Dialisi e Trapianto
city: Torino
country: Italy
facility: Ospedale Martini - S.C. Nefrologia E Dialisi
city: Torino
country: Italy
facility: Ospedale San Giovanni Bosco - Struttura Complessa Nefrologia e Dialisi
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Benalmadena
country: Spain
facility: Xanit Hospital Internacional
state: Málaga
city: Xativa
country: Spain
facility: Hospital Lluis Alcanyis
state: Valencia
city: Barcelona
country: Spain
facility: Fundació Puigvert
city: Barcelona
country: Spain
facility: Hospital de Barcelona
city: Leon
country: Spain
facility: Hospital Universitario de Leon
city: Madrid
country: Spain
facility: Hospital central della Cruz Roja
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
city: Zamora
country: Spain
facility: Hospital Virgen de la Concha
city: Karlskoga
country: Sweden
facility: Karlskoga Lasarett
city: Linköping
country: Sweden
facility: Linköpings Universitetssjukhus
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Njurmedicinska kliniken, Danderyds sjukhus
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: