Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.
EPO-PASS
1 other identifier
interventional
1,695
10 countries
114
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2008
Typical duration for phase_4
114 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2008
CompletedFirst Posted
Study publicly available on registry
March 10, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
July 11, 2017
CompletedJuly 11, 2017
July 1, 2017
1.7 years
February 29, 2008
April 3, 2017
July 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects
The incidence of relevant drug-related adverse events consisting of Epoetin alfa-induced immunogenicity and resulting blockade in erythroid maturation (e.g. pure red cell aplasia) and lack of efficacy
6 months
Study Arms (1)
HX575 epoetin alfa i.v.
EXPERIMENTALThis post-authorization safety study was designed as a multi-center, multinational, prospective, single-arm clinical study with a 6-month HX575 (recombinant human) erythropoietin alfa treatment period. It was planned to include approximately 1,500 patients.
Interventions
HX575 epoetin alfa i.v. will be administered according to the SmPC
Eligibility Criteria
You may qualify if:
- 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 -
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (114)
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
Vienna, 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
Multiprofile Hospital for Active Treatment Sv. Ivan Rilski
Sofia, 1431, Bulgaria
Ministry of Interior-Central Clinical Base
Sofia, 1606, Bulgaria
CHG Hopital Yves le Foll
Saint-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
KfH Nierenzentrum
Berlin, 12247, Germany
Alwall Praxis für Nieren- und Hochdruckkrankheiten
Berlin, 13125, Germany
Dialysepraxis
Bremerhaven, 27570, Germany
Dialysepraxis Drs. Riedasch/Schreiber
Coesfeld, 48653, Germany
KfH Nierenzentrum
Cologne, 50937, 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 im Breisgau, 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 an der Aisch, 91315, Germany
Gemeinschaftspraxis
Kamp-Lintfort, 47475, 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 San Carlo Borromeo
Milan, 20153, Italy
Azienda Ospedaliera Ospedale Niguarda Ca Granda
Milan, 20162, 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, North Macedonia
PHO Health organisation Goce Delcev
Delcevo, 2320, North Macedonia
PHO General Hospital Kocani
Kočani, 2300, North Macedonia
PHO General Hospital Borka Taleski
Prilep, 7500, North Macedonia
PHO General Hospital Stip
Shtip, 1000, North Macedonia
PHO Clinic of Nephrology
Skopje, 1000, North Macedonia
Institute of Nephrology
Struga, 6330, North Macedonia
PHO Medical Center Veles
Veles, 1400, North Macedonia
Specjalistyczny Szpital Wojewodzki w Ciechanowie
Ciechanów, 06-400, Poland
Wojewodzki Szpital Specjalistyczny im. Najswietszej maryi Panny
Częstochowa, 42-200, Poland
Samodzielnym Publicznym Zakladzie Opieki Zdrowotnej Dzialdowo
Działdowo, 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-Dobrzyń, 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 Bielanski Blok F
Warsaw, 01-809, Poland
Centralny Szpital Kliniczny MSWiA
Warsaw, 02-507, Poland
Szpital Powiatowy im. Lekarza Z. Koprowskiego
Warsaw, 08-300, 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, Russia
City Clinal Hospital # 34
Novosibirsk, 630120, Russia
MLPU "Clinical City Hospital # 1"
Smolensk, 214019, Russia
GUZ "Yaroslavl regional clinical hospital"
Yaroslavl, 150062, Russia
Oblasna klinichna likarnia imeni I.I.Mechnikova
Dnipropetrovsk, 49000, Ukraine
Oblasnyi tsentr urologii ta nefrologii
Kharkiv, 61037, Ukraine
Tsentralnyi miskyi klinichnyi hospital, Viddilennia gemodializu
Kyiv, 01023, Ukraine
Miska klinichna likarnia#3, Miskyi nefrologichnyi tsentr
Kyiv, 02125, Ukraine
Instytut nefrologii AMN Ukrainy viddil nefrologii ta dializu
Kyiv, 04050, 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
Related Publications (1)
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.
PMID: 22732334DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biopharmaceutical Clinical Development, Strategic Planning
- Organization
- Sandoz
Study Officials
- STUDY CHAIR
Karsten Roth, Dr
Hexal AG
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2008
First Posted
March 10, 2008
Study Start
July 1, 2008
Primary Completion
March 1, 2010
Study Completion
September 1, 2010
Last Updated
July 11, 2017
Results First Posted
July 11, 2017
Record last verified: 2017-07