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Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.

Information source: Sandoz
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease

Intervention: HX575 recombinant human erythropoietin alfa (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sandoz

Official(s) and/or principal investigator(s):
Karsten Roth, Dr, Study Chair, Affiliation: Hexal AG

Summary

Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among CKD subjects receiving HX575 epoetin alfa i. v.

Clinical Details

Official title: Post-authorization Safety Study to Prospectively Monitor the Incidence of Relevant Drug-related Adverse Events and EPO-related Lack of Efficacy Among CKD Subjects Receiving HX575 Recombinant Human Erythropoietin Alfa i.v.

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Determination of relevant drug-related adverse events and EPO-related lack of efficacy incidence among CKD subjects receiving HX575 epoetin alfa i.v.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- CKD subjects with or without dialysis treatment

- Age over 18 years

- Subjects requiring i. v. ESA treatment

- Subjects likely to remain on i. v. ESA treatment for 6 months

- Provision of informed consent -

Exclusion Criteria:

- Systemic immunosuppressive medication or any other drugs known to adversely affect

the hemoglobin level

- Known primary lack of efficacy (LOE), unexplained loss of effect to a recombinant

erythropoietin product

- History of PRCA or aplastic anemia

- History of anti-erythropoietin antibodies

- Uncontrolled hypertension

- Pregnant woman or nursing mother

- Women of childbearing potential do not agree to maintain effective birth control

during the study treatment period.

Locations and Contacts

Dialysepraxis Dres. Huspek/Schmid, Bad Ischl 4820, Austria

Landeskrankenhaus Feldkirch, Feldkirch 6800, Austria

Landeskrankenhaus Freistadt, Freistadt 4240, Austria

LKH Rohrbach, Rohrbach 4150, Austria

Universitätsklinik für Innere Medizin III, Wien 1090, Austria

Multiprofile Hospital for Active Treatment Dr. Tota Venkova, Gabrovo 5300, Bulgaria

Multiprofile Hospital for Active Treatment Dr. Kiro Popov, Karlovo 4300, Bulgaria

Multiprofile Hospital for Active Treatment Pazardzhik, Pazardzhik 40400, Bulgaria

Multiprofile Hospital for Active Treatment Rousse, Rousse 7002, Bulgaria

Ministry of Interior-Central Clinical Base, Sofia 1606, Bulgaria

Multiprofile Hospital for Active Treatment Sv. Ivan Rilski, Sofia 1431, Bulgaria

CHG Hopital Yves le Foll, St Brieuc 22023, France

Fachpraxis für Nieren und Hochdruckerkrankungen, Andernach 56626, Germany

KfH Kuratorium für Nierentranplantation und Dialyse e.V., Aschaffenburg 63741, Germany

Gemeinschaftspraxis, Baunatal 34225, Germany

Kuratorium ür Dialyse und Nierentransplantation e.V., Bayreuth 95445, Germany

Alwall Praxis für Nieren- und Hochdruckkrankheiten, Berlin 13125, Germany

KfH Nierenzentrum, Berlin 12247, Germany

Dialysepraxis, Bremerhaven 27570, Germany

Dialysepraxis Drs. Riedasch/Schreiber, Coesfeld 48653, Germany

Facharzt für Innere Medizin und Nephrologie, Dialyse Centrum, Darmstadt 64295, Germany

KfH Kuratorium für Nierentranplantation und Dialyse e.V., Deggendorf 94469, Germany

Dialysezentrum, Dinkelsbühl 91550, Germany

Diabetes- und Dialysezentrum Merker, Vogt, Dormagen 41539, Germany

KfH Nierenzentrum, Dortmund 44141, Germany

Gemeinschaftspraxis Karlstraße, Düsseldorf 40210, Germany

Kuratorium für Dialyse und Nierentransplantation e.V., Ehingen 89584, Germany

Dialysezentrum Elsenfeld, Elsenfeld 63820, Germany

Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel, Essen 45127, Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V., Essen 45136, Germany

Dialysezentrum, Freiburg 79110, Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V, Fürstenzell 94081, Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V, Gummersbach 51643, Germany

Dialyse Hamburg Barmbek, Hamburg 22297, Germany

Dialysepraxis Dr. Spengler, Helmstedt 38350, Germany

Marienhospital Herne, Herne 44625, Germany

Dialyse-Zentrum Elsterland, Herzberg 04916, Germany

Praxis Dr. Menzer, Homberg/Efze 34576, Germany

Nephrologische Praxis, Höchstadt 91315, Germany

Gemeinschaftspraxis, Kamp-Lintfort 47475, Germany

KfH Nierenzentrum, Köln 50937, Germany

Dialysepraxis, Lahr 77933, Germany

Praxis für Innere Medizin und Nephrologie, Leverkusen 51373, Germany

Nephrologisches Zentrum Emsland, Lingen 49808, Germany

Dialysezentrum und Schwerpunktpraxis für Nieren- und Hochdruckerkrankungen, Mannheim 68309, Germany

Gemeinschaftspraxis, Mayen 56727, Germany

Nephrologisches Zentrum Mettmann, Mettmann 40822, Germany

KfH Kuratorium für Nierentranplantation und Dialyse e.V., Oberschleißheim 85764, Germany

Nierenzentrum Prenzlau, Prenzlau 17291, Germany

Nephrologische Ambulanz/ Dialyse, Singen 78224, Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V, Straubing 94315, Germany

Nieren- und Diabeteszentrum Viersen-Nettetal, Viersen-Dülken 41751, Germany

IRCCS INRCA Sede de Ancona, Ancona 60100, Italy

Ospedali Riuniti di Anzio e Nettuno, Anzio 00042, Italy

U.O.C. Nefrologia e Dialisi, C.G. Mazzoni, Ascoli Piceno 63100, Italy

Ospedaliero Universitaria Policlinico S. Orsola Malpighi, Bologna 40138, Italy

Azienda Ospdealiero "Istituti Ospitalieri", Cremona 26100, Italy

Ospedale E. Profili di Fabriano, Fabriano 60044, Italy

AO Universitaria Ospedali Riuniti, Foggia 71100, Italy

Universitaria Degli Studi di Genova Clinica Nefrologica, Dialisi e Trapianto, Genova 16132, Italy

Ospedale A. Manzoni, Lecco 23900, Italy

Azienda Ospedaliera Carlo Poma di Mantova, Mantova 46100, Italy

Azienda Ospedaliera Ospedale Niguarda Ca Granda, Milano 20162, Italy

Azienda Ospedaliera Ospedale San Carlo Borromeo, Milano 20153, Italy

AO Universitaria di Modena, Modena 41100, Italy

Ospedale Maggiore di Modica, Modica 97015, Italy

U.O. Nefrologia e Dialisi, P.O. Ospedale Casati, Centro Dialisi, Passirana di Rho 20017, Italy

Fondazione S. Maugeri, Pavia 27100, Italy

Azienda Ospedaliera ospedale S. Salvatore, Pesaro 61100, Italy

Ospedale A. Landolfi, Solofra 83029, Italy

Azienda Ospedaliera CTO - Maria Adelaide, Torino 10126, Italy

Ospedale San Giovanni Bosco, Torino 10154, Italy

Ospedale di Trento / Santa Chiara, Trento 38100, Italy

Ospedale dell'Angelo, Venezia Mestre 30173, Italy

PHO Clinical Hospital Dr. Trifun Panovski, Bitola 7000, Macedonia, The Former Yugoslav Republic of

PHO Health organisation Goce Delcev, Delcevo 2320, Macedonia, The Former Yugoslav Republic of

PHO General Hospital Kocani, Kocani 2300, Macedonia, The Former Yugoslav Republic of

PHO General Hospital Borka Taleski, Prilep 7500, Macedonia, The Former Yugoslav Republic of

PHO Clinic of Nephrology, Skopje 1000, Macedonia, The Former Yugoslav Republic of

PHO General Hospital Stip, Stip 1000, Macedonia, The Former Yugoslav Republic of

Institute of Nephrology, Struga 6330, Macedonia, The Former Yugoslav Republic of

PHO Medical Center Veles, Veles 1400, Macedonia, The Former Yugoslav Republic of

Specjalistyczny Szpital Wojewodzki w Ciechanowie, Ciechanow 06-400, Poland

Wojewodzki Szpital Specjalistyczny im. Najswietszej maryi Panny, Czestochowa 42-200, Poland

Samodzielnym Publicznym Zakladzie Opieki Zdrowotnej Dzialdowo, Dzialdowo 13-200, Poland

Stacja Dializ w Garwolinie, Garwolin 08-400, Poland

Szpital Specjalistyczny Sw. W. Adalberta, Gdansk 80-462, Poland

Niepubliczny Zaklad Opieki Zdrowotnej AVITUM, Golub-Dobrzyn 87-400, Poland

B. Braun AVITUM Poland Sp., Legnica 59-220, Poland

SP Szpital Kliniczny im. Barlickiego, Lodz 90-153, Poland

Samodzielny Publiczny Szpital Kliniczny nr 4, Lublin 20-954, Poland

Niepubliczny Zaklad Opieki Zdrowotnej, Pabianice 95-200, Poland

Radomski Szpital Specjalistyszny im. Dr Tytusa Chalubinskiego, Radom 26-610, Poland

Wojewodzki Szpital Specjalistyczny nr 3, Rybnik 44-200, Poland

Szpital Powiatowy im. Lekarza Z. Koprowskiego, Warsaw 08-300, Poland

Centralny Szpital Kliniczny MSWiA, Warszawa 02-507, Poland

Szpital Bielanski Blok F, Warszawa 01-809, Poland

Spitalul Clinic Municipal, Arad 310017, Romania

Institutul Clinic Fundeni, Bucharest 022328, Romania

Spitalul Clinic de urgenta "Floreasca", Bucharest 14461, Romania

Spitalul Universitar de Urgenta, Bucharest 50098, Romania

SC Renamed Nefrodial SRL, Oradea 410562, Romania

FGUZ Clinical hospital No. 83 of FMBA of Russia, Moscow 115682, Russian Federation

City Clinal Hospital # 34, Novosibirsk 630120, Russian Federation

MLPU "Clinical City Hospital # 1", Smolensk 214019, Russian Federation

GUZ "Yaroslavl regional clinical hospital", Yaroslavl 150062, Russian Federation

Oblasna klinichna likarnia imeni I.I.Mechnikova, Dnipropetrovsk 49000, Ukraine

Oblasnyi tsentr urologii ta nefrologii, Kharkiv 61037, Ukraine

Instytut nefrologii AMN Ukrainy viddil nefrologii ta dializu, Kyiv 04050, Ukraine

Miska klinichna likarnia#3, Miskyi nefrologichnyi tsentr, Kyiv 02125, Ukraine

Tsentralnyi miskyi klinichnyi hospital, Viddilennia gemodializu, Kyiv 01023, Ukraine

Mykolaivska Oblasna Klinichna Likarnia, Viddilennia Gemodializu, Mykolayiv 54058, Ukraine

Ternopilska Oblasna Klinichna Likarnia, Viddilennia Nefrologii ta Gemodializu, Ternopil 46002, Ukraine

Oblasna klinikchna likarnia, tsentr transplantologii ta gemodializu, Zaporizhzhya 69050, Ukraine

Additional Information

Starting date: July 2008
Last updated: June 1, 2015

Page last updated: August 20, 2015

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