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Renal AnemiaPASCO IINCT01543477

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

An observational study of Renal Anemia and Pregnancy, run by Pfizer at 179 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 years and older
Conditions the study is for
Renal Anemia, Pregnancy, Lactation
How many people
4,501 participants
Where
179 sitesin 12 countries
Study dates
7 Jul 2010to 29 Apr 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients currently under treatment with Retacrit (epoetin zeta) administered subcutaneously for renal anaemia.

Who may be able to join

  • 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

Who cannot join

  • Any contraindications as per the current Summary of Product Characteristics (SPC) of Retacrit™

Trial locations and contacts

179 sites in 12 countries.

179 sites in 12 countries

Greece47 sites

  • General Hospital of Rhodes

    Agioi Apostoloi, 851 00

  • General Hospital of Agios Nikolaos

    Agios Nikolaos, Crete, 721 00

  • Private Physician

    Agrinio, 30100

  • Office of Eleni Stefanopoulou/Private Physician

    Aigáleo, 12243

  • University General Hospital of Alexandroupoli

    Alexandroupoli, 681 00

  • Polikliniki Athinon

    Athens, 10682

  • Therapeutical Department "ATTIKO"

    Athens, 113 62

  • General Hospital Gennimata

    Athens, 115 27

  • General Hospital "Alexandra"

    Athens, 115 28

  • Errikos Ntinan Hospital

    Athens, 11526

  • Kyanos Stavros

    Athens, 11526

  • Aretaiion Hospital

    Athens, 11528

  • General University Hospital "ATTIKO"

    Athens, 124 62

  • General Hospital of Athens "A.Fleming"

    Athens, 151 27

  • Private Physician

    Athens, 15235

  • General Hospital of Chania

    Chania, Crete, 733 00

  • Didimoticho General Hospital

    Didimoticho, 683 00

  • Drama General Hospital

    Drama, 661 00

  • Edessa General Hospital

    Edessa, 582 00

  • General Hospital of Filiates

    Filiátes, 463 00

  • General Hospital of Grevena

    Grevená, 511 00

  • Kavala General Hospital

    Kavala, 655 00

  • General Hospital of Komotini Sismanogleio

    Komotini, 691 00

  • Private Physician

    Kozani, 50100

  • General Hospital of Kyparissia

    Kyparissía, 245 00

  • Private Physician

    Lamia, 35100

  • General University Hospital of Larisa

    Larissa, 413 34

  • General Clinic Eftichios Patsidis

    Larissa, 41335

  • General Hospital of Mesologgi

    Mesologgi, 30200

  • Private Physician

    Nea Raidestos, Thessaloniki, 57001

  • General Hospital Agios Andreas

    Pátrai, 26 335

  • General Hospital of Prolemaida

    Ptolemaida, 502 00

  • Serres general Hospital

    Serres, 621 00

  • AHEPA University Hospital

    Thessaloniki, 546 36

  • Ippokrateion General Hospital

    Thessaloniki, 546 39

  • Private Physician

    Thessaloniki, 54642

  • Private Physician

    Thessaloniki, 56224

  • Papageorgiou General Hospital

    Thessaloniki, 564 29

  • Private Physician

    Thessaloniki, 56431

  • "Diavalkaniko" Therareutical Center

    Thessaloniki, 570 01

  • Therapeutical Department of Thermi

    Thessaloniki, 570 01

  • Papanikolaou General Hospital

    Thessaloniki, 570 10

  • Private Physician

    Véria, 59100

  • Thessaliki Nosileutiki EPE

    Volos, 38221

  • General Hospital "Asklipeiio Voulas"

    Voula, Attica, 166 73

  • Private Physician

    Voula, 166 75

  • Private Physician

    Voula, 16673

Other trials in Greece

Germany46 sites

  • Nephrologische Gemeinschaftspraxis

    Alsfeld, 36304

  • PHV Dialysezentrum Alsfeld

    Alsfeld, 36304

  • MVZ DaVita Alzey GmbH

    Alzey, 55232

  • Gemeinschaftspraxis Dr. Gööck & Dr. Anger

    Arnstadt, 99310

  • MVZ Bad Bevensen

    Bad Bevensen, 29549

  • Nephrologische Gemeinschaftspraxis

    Bad Homburg, 61352

  • Nephrologsiche Praxis

    Bad König, 64732

  • Internistische Praxis und Nephrologie

    Bad Nauheim, 61231

  • Nieren-und Hochdruckzentrum

    Bad Wildungen, 34537

  • Praxis F. Nierenkrankheiten/Tagesklinik

    Berlin, 12627

  • Gesundheitszentrum HSH

    Berlin, 13051

  • Alwall-Haus Dialysezentrum Berlin

    Berlin, 13125

  • Dialyse am Kurfürstendamm

    Berlin, 14193

  • Praxis Marsen

    Cologne, 50937

  • Dialyse Centrum Darmstadt

    Darmstadt, 64295

  • MVZ DaVita Dormagen GmbH

    Dormagen, 41540

  • KfH Nierenzentrum

    Essen, 45136

  • Praxis für Nephrologie

    Frankenthal, 67227

  • Nierenzentrum Heppenheim

    Heppenheim an der Bergstrasse, 64646

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

    Herne, 44623

  • DaVita Elsterland

    Herzberg, 04916

  • Dialyse T. Menzer Homberg-Efze

    Homberg (Efze), 34576

  • Nephrologische Gemeinschaftspraxis und Dialysezentrum

    Hoyerswerda, 02977

  • Gemeinschaftspraxis Grahl und Johnen

    Hürth-Hermülheim, 50354

  • Westpfalz-Klinikum Kaiserslautern

    Kaiserslautern, 67655

  • Nieren- und Hochdruckzentrum Kiel

    Kiel, 24106

  • Medizinisches Versorgungszentrum MVZ Diaverum Kleve GmbH

    Kleve, 47533

  • Praxis Dres. Schoenwald und Beck

    Langenfeld, 40764

  • Nephrologische Praxis

    Langenselbold, 63505

  • Nierenzentrum Leverkusen

    Leverkusen, 51373

  • Nephrologische Gemeinschaftspraxis

    Lübeck, 23562

  • Märkische Kliniken GmbH Klinikum Lüdenscheid

    Lüdenscheid, 58515

  • Dialysezentrum Ludwigslust

    Ludwigslust, 19288

  • Dialysezentrum Stadtfeld

    Magdeburg, 39108

  • Nephrologische Praxis

    Mayen, 56727

  • Nephrologisches Zentrum

    Mettmann, 40822

  • Nephrologische Gemeinschaftspraxis

    Mühlhausen, 99974

  • MVZ DaVita Viersen GmbH

    Nettetal, 41334

  • ze:ro Dialysezentren und Gemeinschaftspraxis

    Neustadt, 67433

  • Nephrologisches- und Dialysezentrum Niebüll

    Niebüll, 25899

  • Klinikum Ernst von Bergmann

    Potsdam, 14467

  • Dialysezentrum

    Quedlinburg, 06484

  • Gemeinschaftspraxis Schuerfeld Moeller Henrich

    Saarlouis, 66740

  • Städtisches Klinikum Solingen Abt. Nephrologie - Innere Medizin

    Solingen, 42653

  • Dialysezentrum Tangermünde

    Tangermünde, 39590

  • Deutsche Klinik fuer Diagnostik Department of Nephrology

    Wiesbaden, 65191

Other trials in Germany

Italy33 sites

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

    Ancona, 60020

  • Ospedali Riuniti Anzio-Nettuno, Nefrologia e Dialisi ASL RMH

    Anzio (RM), 00042

  • Centro Dialisi Nefrologia - Ospedale S. Donato Arezzo

    Arezzo, 52100

  • Dipartimento di Nefrologia- Ospedale Mazzoni

    Ascoli Piceno, 63100

  • P.O. S.G. Moscati

    Aversa (NA), 80031

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

    Chieri (TO), 10023

  • Azienda Ospedaliera S. Anna

    Cona-Ferrara, Ferrara, 44124

  • AOU Careggi Hospital Firenze

    Florence, 50134

  • Ospedale della Misericordia USL9

    Grosseto, 58100

  • Dipartimento di Nefrologia Ospedale Versilia-Viareggio (Lucca)

    Lido Di Camaiore (Lucca), 55043

  • U.O. Nefrologia Lucca

    Lucca, 55100

  • U.O. Nefrologia e Dialisi ULSS12

    Mestre, 30174

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

    Milan, 20126

  • A.O. MONALDI- Dept nephrology and Dialysis

    Naples, 80100

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

    Naples, 80131

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

    Naples, 80131

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

    Naples, 80131

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

    Nocera Inferiore (SA), 84014

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

    Nola (NA), 80035

  • Dipartimento di Medicina -DIMED- Policlinico Padova

    Padova, 35128

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

    Pavia, 27100

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

    PISA (Cisanello), 56124

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

    Pistoia, 51100

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

    San Miniato, PISA, 56027

  • U.O.C. Nefrologia e Dialisi Azienda Ospedaliera

    San Sebastiano, 81100

  • Presidio ospesdaliero G.CRISCUOLI - UO DIALISI

    Sant'Angelo dei Lombardi, Avellino, 83054

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

    Santa Maria Capua Vetere, CE, 81055

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

    Siena, 53100

  • "Presidio Ospedaliero" di Soverato - Servizio Dialisi

    Soverato Marina, Catanzaro, 88068

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

    Torino, 10126

  • Ospedale Martini - S.C. Nefrologia E Dialisi

    Torino, 10141

  • Ospedale San Giovanni Bosco - Struttura Complessa Nefrologia e Dialisi

    Torino, 10154

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

    Zingonia- Osio Sotto, Bergamo, 24040

Other trials in Italy

Bulgaria14 sites

  • MHAT "Dr. Tota Venkova"AD

    Gabrovo, 5300

  • MHAT "Dr. Stamen Iliev"AD

    Montana, 3400

  • UMHAT "Georgi Stranski" EAD

    Pleven, 5800

  • Dutchmed Dialysis Clinic (in the building of 5 DCC)

    Plovdiv, 4023

  • MHAT Plodiv AD

    Plovdiv, 4027

  • MHAT "Dr. Bratan Shukerov" AD

    Smolyan, 4700

  • Fifth MHAT EAD

    Sofia, 1233

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

    Sofia, 1407

  • University Hospital Lozenets

    Sofia, 1407

  • UMHAT "Alexandrovska" EAD

    Sofia, 1431

  • SHATPD "Prof. Ivan Mitev"EAD

    Sofia, 1606

  • DCC "Sveta Anna" Sofia

    Sofia, 1709

  • Kidney center - Medical center EOOD

    Varna, 9010

  • UMHAT "Sveta Marina"EAD

    Varna, 9010

Other trials in Bulgaria

France10 sites

  • CHU Amiens-Picardie Site Sud,, service de Nefrologie

    Amiens (Salouel) Cedex 1, 80054

  • CHU Amiens-Picardie Site Sud

    Amiens (Salouel) Cedex 1, 80054

  • Centre Hospitalier de Cahors

    Cahors, 46005

  • Aura Auvergne Chamalières

    Chamalières, 63400

  • Hospital Gabriel Montpied, Centre de Dialyse

    Clermont-Ferrand, 63000

  • 35 Nephrologie Centre Medico Chirurgical de l'Europe

    Le Port-Marly, 78560

  • Polyclinique de la Louvière, Service Hemodialyse Nephrologie CHSA Maubeuge

    Lille, 59800

  • Aura Paris Plaisance

    Paris, 75014

  • Aura Notre Dame de Bon Secours

    Paris

  • Hopital de Rangueil, service de nephrologie

    Toulouse, 31059

Other trials in France

Spain10 sites

  • Fundació Puigvert

    Barcelona, 08025

  • Hospital de Barcelona

    Barcelona, 08034

  • Xanit Hospital Internacional

    Benalmádena, Málaga, 29630

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid, 28942

  • Hospital Universitario de Leon

    León, 24071

  • Hospital central della Cruz Roja

    Madrid, 28003

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Parc Taulí

    Sabadell, 08208

  • Hospital Lluis Alcanyis

    Xàtiva, Valencia, 46800

  • Hospital Virgen de la Concha

    Zamora, 49022

Other trials in Spain

Croatia9 sites

  • County Hospital Cakovec

    Čakovec, 40000

  • General Hospital Dubrovnik

    Dubrovnik, 20000

  • General Hospital Karlovac

    Karlovac, 47000

  • Health Center Labin

    Labin, 52220

  • University Hospital Centre Osijek

    Osijek, 31000

  • General Hospital Sibenik

    Šibenik, 22000

  • Health Center Umag

    Umag, 52470

  • University Hospital Centre Zagreb

    Zagreb, 10000

  • University Hospital Merkur

    Zagreb, 10000

Other trials in Croatia

Sweden4 sites

  • Karlskoga Lasarett

    Karlskoga, 69181

  • Linköpings Universitetssjukhus

    Linköping, 58185

  • Karolinska University Hospital

    Stockholm, 14186

  • Njurmedicinska kliniken, Danderyds sjukhus

    Stockholm, 18288

Other trials in Sweden

Finland3 sites

  • Div. of Nephrology, Helsinki University HospitalHUS Kirurginen sairaala

    Helsinki, 00290

  • Pietarsaari Hospital Medical clinic

    Jakobstad, 68601

  • Kainuu Hospital

    Kajaani, 87140

Other trials in Finland

Denmark1 site

  • Department of Renal Medicine Medicinerhuset 3 sal Aalborg University Hospital

    Aalborg, 9100

Other trials in Denmark

Ireland1 site

  • Merlin Park Dialysis Unit

    Galway

Other trials in Ireland

United Kingdom1 site

  • Kings College Hospital

    London, SE5 9RS

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01543477
Study groupRoleWhat they receive
Single groupNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence Rate of Adverse Events of Special Interest

    Ongoing routine doctor visits for 156 weeks

    Measured: 156 weeks

Secondary outcomes (3)

  1. Adverse drug reactions

    Descriptive evaluation including incidence rates of adverse drug reactions.

    Measured: 156 weeks

  2. Information on treatment with Retacrit during pregnancy and lactation

    Measured: 156 weeks

  3. Data on long term use

    Measured: 156 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2012 (estimated)
  2. Study start7 Jul 2010
  3. Primary completion29 Apr 2020
  4. Study completion29 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,501 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01543477
Sponsor's protocol ID
EPOE-09-11
Other IDs
C1111006, PASCO II
Acronym
PASCO II
Status last verified
Sep 2020
First submitted
21 Feb 2012
Last updated
1 Oct 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Anemia and Pregnancy, run by Pfizer at 179 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 179 sites in Greece, Germany, Italy, Bulgaria, France and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Rate of Adverse Events of Special Interest (time frame: 156 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01543477.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.

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