Clinical trial NCT00632125: Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Keywords: CKD subjects with or without dialysis treatment
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
Collaborators: name: Hexal AG
First posted: 2008-03-10
Enrollment: 1695
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 Chronic Kidney Disease (CKD) subjects receiving HX575 epoetin alfa i.v.

Detailed description: This study was a multi-center, multinational, prospective, single-arm clinical study with a 6-month treatment period. The primary objective was to extend the safety database of patients with CKD who receive i.v. HX575 epoetin alfa treatment and to monitor the adverse event (AE) profile under post-approval conditions.

Eligibility 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.

Primary outcomes:
measure: Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Ischl
country: Austria
facility: Dialysepraxis Dres. Huspek/Schmid
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Freistadt
country: Austria
facility: Landeskrankenhaus Freistadt
city: Rohrbach
country: Austria
facility: LKH Rohrbach
city: Wien
country: Austria
facility: Universitätsklinik für Innere Medizin III
city: Gabrovo
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Dr. Tota Venkova
city: Karlovo
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Dr. Kiro Popov
city: Pazardzhik
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Pazardzhik
city: Rousse
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Rousse
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Sv. Ivan Rilski
city: Sofia
country: Bulgaria
facility: Ministry of Interior-Central Clinical Base
city: St Brieuc
country: France
facility: CHG Hopital Yves le Foll
city: Andernach
country: Germany
facility: Fachpraxis für Nieren und Hochdruckerkrankungen
city: Aschaffenburg
country: Germany
facility: KfH Kuratorium für Nierentranplantation und Dialyse e.V.
city: Baunatal
country: Germany
facility: Gemeinschaftspraxis
city: Bayreuth
country: Germany
facility: Kuratorium ür Dialyse und Nierentransplantation e.V.
city: Berlin
country: Germany
facility: KfH Nierenzentrum
city: Berlin
country: Germany
facility: Alwall Praxis für Nieren- und Hochdruckkrankheiten
city: Bremerhaven
country: Germany
facility: Dialysepraxis
city: Coesfeld
country: Germany
facility: Dialysepraxis Drs. Riedasch/Schreiber
city: Darmstadt
country: Germany
facility: Facharzt für Innere Medizin und Nephrologie, Dialyse Centrum
city: Deggendorf
country: Germany
facility: KfH Kuratorium für Nierentranplantation und Dialyse e.V.
city: Dinkelsbühl
country: Germany
facility: Dialysezentrum
city: Dormagen
country: Germany
facility: Diabetes- und Dialysezentrum Merker, Vogt
city: Dortmund
country: Germany
facility: KfH Nierenzentrum
city: Düsseldorf
country: Germany
facility: Gemeinschaftspraxis Karlstraße
city: Ehingen
country: Germany
facility: Kuratorium für Dialyse und Nierentransplantation e.V.
city: Elsenfeld
country: Germany
facility: Dialysezentrum Elsenfeld
city: Essen
country: Germany
facility: Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel
city: Essen
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
city: Freiburg
country: Germany
facility: Dialysezentrum
city: Fürstenzell
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Gummersbach
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Hamburg
country: Germany
facility: Dialyse Hamburg Barmbek
city: Helmstedt
country: Germany
facility: Dialysepraxis Dr. Spengler
city: Herne
country: Germany
facility: Marienhospital Herne
city: Herzberg
country: Germany
facility: Dialyse-Zentrum Elsterland
city: Homberg/Efze
country: Germany
facility: Praxis Dr. Menzer
city: Höchstadt
country: Germany
facility: Nephrologische Praxis
city: Kamp-Lintfort
country: Germany
facility: Gemeinschaftspraxis
city: Köln
country: Germany
facility: KfH Nierenzentrum
city: Lahr
country: Germany
facility: Dialysepraxis
city: Leverkusen
country: Germany
facility: Praxis für Innere Medizin und Nephrologie
city: Lingen
country: Germany
facility: Nephrologisches Zentrum Emsland
city: Mannheim
country: Germany
facility: Dialysezentrum und Schwerpunktpraxis für Nieren- und Hochdruckerkrankungen
city: Mayen
country: Germany
facility: Gemeinschaftspraxis
city: Mettmann
country: Germany
facility: Nephrologisches Zentrum Mettmann
city: Oberschleißheim
country: Germany
facility: KfH Kuratorium für Nierentranplantation und Dialyse e.V.
city: Prenzlau
country: Germany
facility: Nierenzentrum Prenzlau
city: Singen
country: Germany
facility: Nephrologische Ambulanz/ Dialyse
city: Straubing
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Viersen-Dülken
country: Germany
facility: Nieren- und Diabeteszentrum Viersen-Nettetal
city: Ancona
country: Italy
facility: IRCCS INRCA Sede de Ancona
city: Anzio
country: Italy
facility: Ospedali Riuniti di Anzio e Nettuno
city: Ascoli Piceno
country: Italy
facility: U.O.C. Nefrologia e Dialisi, C.G. Mazzoni
city: Bologna
country: Italy
facility: Ospedaliero Universitaria Policlinico S. Orsola Malpighi
city: Cremona
country: Italy
facility: Azienda Ospdealiero "Istituti Ospitalieri"
city: Fabriano
country: Italy
facility: Ospedale E. Profili di Fabriano
city: Foggia
country: Italy
facility: AO Universitaria Ospedali Riuniti
city: Genova
country: Italy
facility: Universitaria Degli Studi di Genova Clinica Nefrologica, Dialisi e Trapianto
city: Lecco
country: Italy
facility: Ospedale A. Manzoni
city: Mantova
country: Italy
facility: Azienda Ospedaliera Carlo Poma di Mantova
city: Milano
country: Italy
facility: Azienda Ospedaliera Ospedale San Carlo Borromeo
city: Milano
country: Italy
facility: Azienda Ospedaliera Ospedale Niguarda Ca Granda
city: Modena
country: Italy
facility: AO Universitaria di Modena
city: Modica
country: Italy
facility: Ospedale Maggiore di Modica
city: Passirana di Rho
country: Italy
facility: U.O. Nefrologia e Dialisi, P.O. Ospedale Casati, Centro Dialisi
city: Pavia
country: Italy
facility: Fondazione S. Maugeri
city: Pesaro
country: Italy
facility: Azienda Ospedaliera ospedale S. Salvatore
city: Solofra
country: Italy
facility: Ospedale A. Landolfi
city: Torino
country: Italy
facility: Azienda Ospedaliera CTO - Maria Adelaide
city: Torino
country: Italy
facility: Ospedale San Giovanni Bosco
city: Trento
country: Italy
facility: Ospedale di Trento / Santa Chiara
city: Venezia Mestre
country: Italy
facility: Ospedale dell'Angelo
city: Bitola
country: Macedonia, The Former Yugoslav Republic of
facility: PHO Clinical Hospital Dr. Trifun Panovski
city: Delcevo
country: Macedonia, The Former Yugoslav Republic of
facility: PHO Health organisation Goce Delcev
city: Kocani
country: Macedonia, The Former Yugoslav Republic of
facility: PHO General Hospital Kocani
city: Prilep
country: Macedonia, The Former Yugoslav Republic of
facility: PHO General Hospital Borka Taleski
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: PHO Clinic of Nephrology
city: Stip
country: Macedonia, The Former Yugoslav Republic of
facility: PHO General Hospital Stip
city: Struga
country: Macedonia, The Former Yugoslav Republic of
facility: Institute of Nephrology
city: Veles
country: Macedonia, The Former Yugoslav Republic of
facility: PHO Medical Center Veles
city: Ciechanow
country: Poland
facility: Specjalistyczny Szpital Wojewodzki w Ciechanowie
city: Czestochowa
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. Najswietszej maryi Panny
city: Dzialdowo
country: Poland
facility: Samodzielnym Publicznym Zakladzie Opieki Zdrowotnej Dzialdowo
city: Garwolin
country: Poland
facility: Stacja Dializ w Garwolinie
city: Gdansk
country: Poland
facility: Szpital Specjalistyczny Sw. W. Adalberta
city: Golub-Dobrzyn
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej AVITUM
city: Legnica
country: Poland
facility: B. Braun AVITUM Poland Sp.
city: Lodz
country: Poland
facility: SP Szpital Kliniczny im. Barlickiego
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 4
city: Pabianice
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej
city: Radom
country: Poland
facility: Radomski Szpital Specjalistyszny im. Dr Tytusa Chalubinskiego
city: Rybnik
country: Poland
facility: Wojewodzki Szpital Specjalistyczny nr 3
city: Warsaw
country: Poland
facility: Szpital Powiatowy im. Lekarza Z. Koprowskiego
city: Warszawa
country: Poland
facility: Szpital Bielanski Blok F
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA
city: Arad
country: Romania
facility: Spitalul Clinic Municipal
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni
city: Bucharest
country: Romania
facility: Spitalul Clinic de urgenta "Floreasca"
city: Bucharest
country: Romania
facility: Spitalul Universitar de Urgenta
city: Oradea
country: Romania
facility: SC Renamed Nefrodial SRL
city: Moscow
country: Russian Federation
facility: FGUZ Clinical hospital No. 83 of FMBA of Russia
city: Novosibirsk
country: Russian Federation
facility: City Clinal Hospital # 34
city: Smolensk
country: Russian Federation
facility: MLPU "Clinical City Hospital # 1"
city: Yaroslavl
country: Russian Federation
facility: GUZ "Yaroslavl regional clinical hospital"
city: Dnipropetrovsk
country: Ukraine
facility: Oblasna klinichna likarnia imeni I.I.Mechnikova
city: Kharkiv
country: Ukraine
facility: Oblasnyi tsentr urologii ta nefrologii
city: Kyiv
country: Ukraine
facility: Tsentralnyi miskyi klinichnyi hospital, Viddilennia gemodializu
city: Kyiv
country: Ukraine
facility: Miska klinichna likarnia#3, Miskyi nefrologichnyi tsentr
city: Kyiv
country: Ukraine
facility: Instytut nefrologii AMN Ukrainy viddil nefrologii ta dializu
city: Mykolayiv
country: Ukraine
facility: Mykolaivska Oblasna Klinichna Likarnia, Viddilennia Gemodializu
city: Ternopil
country: Ukraine
facility: Ternopilska Oblasna Klinichna Likarnia, Viddilennia Nefrologii ta Gemodializu
city: Zaporizhzhya
country: Ukraine
facility: Oblasna klinikchna likarnia, tsentr transplantologii ta gemodializu
Study officials:
affiliation: Hexal AG
name: Karsten Roth, Dr
role: STUDY_CHAIR
References:
citation: Horl WH, Locatelli F, Haag-Weber M, Ode M, Roth K; Epo-PASS study group. Prospective multicenter study of HX575 (biosimilar epoetin-alpha) in patients with chronic kidney disease applying a target hemoglobin of 10--12 g/dl. Clin Nephrol. 2012 Jul;78(1):24-32. doi: 10.5414/cn107440.