search
Back to results

Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v. (EPO-PASS)

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
HX575 recombinant human erythropoietin alfa
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring CKD subjects with or without dialysis treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dialysepraxis Dres. Huspek/Schmid
  • Landeskrankenhaus Feldkirch
  • Landeskrankenhaus Freistadt
  • LKH Rohrbach
  • Universitätsklinik für Innere Medizin III
  • Multiprofile Hospital for Active Treatment Dr. Tota Venkova
  • Multiprofile Hospital for Active Treatment Dr. Kiro Popov
  • Multiprofile Hospital for Active Treatment Pazardzhik
  • Multiprofile Hospital for Active Treatment Rousse
  • Multiprofile Hospital for Active Treatment Sv. Ivan Rilski
  • Ministry of Interior-Central Clinical Base
  • CHG Hopital Yves le Foll
  • Fachpraxis für Nieren und Hochdruckerkrankungen
  • KfH Kuratorium für Nierentranplantation und Dialyse e.V.
  • Gemeinschaftspraxis
  • Kuratorium ür Dialyse und Nierentransplantation e.V.
  • KfH Nierenzentrum
  • Alwall Praxis für Nieren- und Hochdruckkrankheiten
  • Dialysepraxis
  • Dialysepraxis Drs. Riedasch/Schreiber
  • Facharzt für Innere Medizin und Nephrologie, Dialyse Centrum
  • KfH Kuratorium für Nierentranplantation und Dialyse e.V.
  • Dialysezentrum
  • Diabetes- und Dialysezentrum Merker, Vogt
  • KfH Nierenzentrum
  • Gemeinschaftspraxis Karlstraße
  • Kuratorium für Dialyse und Nierentransplantation e.V.
  • Dialysezentrum Elsenfeld
  • Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel
  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.
  • Dialysezentrum
  • KfH Kuratorium für Dialyse und Nierentransplantation e.V
  • KfH Kuratorium für Dialyse und Nierentransplantation e.V
  • Dialyse Hamburg Barmbek
  • Dialysepraxis Dr. Spengler
  • Marienhospital Herne
  • Dialyse-Zentrum Elsterland
  • Praxis Dr. Menzer
  • Nephrologische Praxis
  • Gemeinschaftspraxis
  • KfH Nierenzentrum
  • Dialysepraxis
  • Praxis für Innere Medizin und Nephrologie
  • Nephrologisches Zentrum Emsland
  • Dialysezentrum und Schwerpunktpraxis für Nieren- und Hochdruckerkrankungen
  • Gemeinschaftspraxis
  • Nephrologisches Zentrum Mettmann
  • KfH Kuratorium für Nierentranplantation und Dialyse e.V.
  • Nierenzentrum Prenzlau
  • Nephrologische Ambulanz/ Dialyse
  • KfH Kuratorium für Dialyse und Nierentransplantation e.V
  • Nieren- und Diabeteszentrum Viersen-Nettetal
  • IRCCS INRCA Sede de Ancona
  • Ospedali Riuniti di Anzio e Nettuno
  • U.O.C. Nefrologia e Dialisi, C.G. Mazzoni
  • Ospedaliero Universitaria Policlinico S. Orsola Malpighi
  • Azienda Ospdealiero "Istituti Ospitalieri"
  • Ospedale E. Profili di Fabriano
  • AO Universitaria Ospedali Riuniti
  • Universitaria Degli Studi di Genova Clinica Nefrologica, Dialisi e Trapianto
  • Ospedale A. Manzoni
  • Azienda Ospedaliera Carlo Poma di Mantova
  • Azienda Ospedaliera Ospedale San Carlo Borromeo
  • Azienda Ospedaliera Ospedale Niguarda Ca Granda
  • AO Universitaria di Modena
  • Ospedale Maggiore di Modica
  • U.O. Nefrologia e Dialisi, P.O. Ospedale Casati, Centro Dialisi
  • Fondazione S. Maugeri
  • Azienda Ospedaliera ospedale S. Salvatore
  • Ospedale A. Landolfi
  • Azienda Ospedaliera CTO - Maria Adelaide
  • Ospedale San Giovanni Bosco
  • Ospedale di Trento / Santa Chiara
  • Ospedale dell'Angelo
  • PHO Clinical Hospital Dr. Trifun Panovski
  • PHO Health organisation Goce Delcev
  • PHO General Hospital Kocani
  • PHO General Hospital Borka Taleski
  • PHO Clinic of Nephrology
  • PHO General Hospital Stip
  • Institute of Nephrology
  • PHO Medical Center Veles
  • Specjalistyczny Szpital Wojewodzki w Ciechanowie
  • Wojewodzki Szpital Specjalistyczny im. Najswietszej maryi Panny
  • Samodzielnym Publicznym Zakladzie Opieki Zdrowotnej Dzialdowo
  • Stacja Dializ w Garwolinie
  • Szpital Specjalistyczny Sw. W. Adalberta
  • Niepubliczny Zaklad Opieki Zdrowotnej AVITUM
  • B. Braun AVITUM Poland Sp.
  • SP Szpital Kliniczny im. Barlickiego
  • Samodzielny Publiczny Szpital Kliniczny nr 4
  • Niepubliczny Zaklad Opieki Zdrowotnej
  • Radomski Szpital Specjalistyszny im. Dr Tytusa Chalubinskiego
  • Wojewodzki Szpital Specjalistyczny nr 3
  • Szpital Powiatowy im. Lekarza Z. Koprowskiego
  • Szpital Bielanski Blok F
  • Centralny Szpital Kliniczny MSWiA
  • Spitalul Clinic Municipal
  • Institutul Clinic Fundeni
  • Spitalul Clinic de urgenta "Floreasca"
  • Spitalul Universitar de Urgenta
  • SC Renamed Nefrodial SRL
  • FGUZ Clinical hospital No. 83 of FMBA of Russia
  • City Clinal Hospital # 34
  • MLPU "Clinical City Hospital # 1"
  • GUZ "Yaroslavl regional clinical hospital"
  • Oblasna klinichna likarnia imeni I.I.Mechnikova
  • Oblasnyi tsentr urologii ta nefrologii
  • Tsentralnyi miskyi klinichnyi hospital, Viddilennia gemodializu
  • Miska klinichna likarnia#3, Miskyi nefrologichnyi tsentr
  • Instytut nefrologii AMN Ukrainy viddil nefrologii ta dializu
  • Mykolaivska Oblasna Klinichna Likarnia, Viddilennia Gemodializu
  • Ternopilska Oblasna Klinichna Likarnia, Viddilennia Nefrologii ta Gemodializu
  • Oblasna klinikchna likarnia, tsentr transplantologii ta gemodializu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HX575 epoetin alfa i.v.

Arm Description

This 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 29, 2008
Last Updated
July 10, 2017
Sponsor
Sandoz
Collaborators
Hexal AG
search

1. Study Identification

Unique Protocol Identification Number
NCT00632125
Brief Title
Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.
Acronym
EPO-PASS
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz
Collaborators
Hexal AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
CKD subjects with or without dialysis treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1695 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HX575 epoetin alfa i.v.
Arm Type
Experimental
Arm Description
This 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.
Intervention Type
Drug
Intervention Name(s)
HX575 recombinant human erythropoietin alfa
Other Intervention Name(s)
HX575 epoetin alfa
Intervention Description
HX575 epoetin alfa i.v. will be administered according to the SmPC
Primary Outcome Measure Information:
Title
Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karsten Roth, Dr
Organizational Affiliation
Hexal AG
Official's Role
Study Chair
Facility Information:
Facility Name
Dialysepraxis Dres. Huspek/Schmid
City
Bad Ischl
ZIP/Postal Code
4820
Country
Austria
Facility Name
Landeskrankenhaus Feldkirch
City
Feldkirch
ZIP/Postal Code
6800
Country
Austria
Facility Name
Landeskrankenhaus Freistadt
City
Freistadt
ZIP/Postal Code
4240
Country
Austria
Facility Name
LKH Rohrbach
City
Rohrbach
ZIP/Postal Code
4150
Country
Austria
Facility Name
Universitätsklinik für Innere Medizin III
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Multiprofile Hospital for Active Treatment Dr. Tota Venkova
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Dr. Kiro Popov
City
Karlovo
ZIP/Postal Code
4300
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Pazardzhik
City
Pazardzhik
ZIP/Postal Code
40400
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Rousse
City
Rousse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Sv. Ivan Rilski
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Ministry of Interior-Central Clinical Base
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
CHG Hopital Yves le Foll
City
St Brieuc
ZIP/Postal Code
22023
Country
France
Facility Name
Fachpraxis für Nieren und Hochdruckerkrankungen
City
Andernach
ZIP/Postal Code
56626
Country
Germany
Facility Name
KfH Kuratorium für Nierentranplantation und Dialyse e.V.
City
Aschaffenburg
ZIP/Postal Code
63741
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Baunatal
ZIP/Postal Code
34225
Country
Germany
Facility Name
Kuratorium ür Dialyse und Nierentransplantation e.V.
City
Bayreuth
ZIP/Postal Code
95445
Country
Germany
Facility Name
KfH Nierenzentrum
City
Berlin
ZIP/Postal Code
12247
Country
Germany
Facility Name
Alwall Praxis für Nieren- und Hochdruckkrankheiten
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Dialysepraxis
City
Bremerhaven
ZIP/Postal Code
27570
Country
Germany
Facility Name
Dialysepraxis Drs. Riedasch/Schreiber
City
Coesfeld
ZIP/Postal Code
48653
Country
Germany
Facility Name
Facharzt für Innere Medizin und Nephrologie, Dialyse Centrum
City
Darmstadt
ZIP/Postal Code
64295
Country
Germany
Facility Name
KfH Kuratorium für Nierentranplantation und Dialyse e.V.
City
Deggendorf
ZIP/Postal Code
94469
Country
Germany
Facility Name
Dialysezentrum
City
Dinkelsbühl
ZIP/Postal Code
91550
Country
Germany
Facility Name
Diabetes- und Dialysezentrum Merker, Vogt
City
Dormagen
ZIP/Postal Code
41539
Country
Germany
Facility Name
KfH Nierenzentrum
City
Dortmund
ZIP/Postal Code
44141
Country
Germany
Facility Name
Gemeinschaftspraxis Karlstraße
City
Düsseldorf
ZIP/Postal Code
40210
Country
Germany
Facility Name
Kuratorium für Dialyse und Nierentransplantation e.V.
City
Ehingen
ZIP/Postal Code
89584
Country
Germany
Facility Name
Dialysezentrum Elsenfeld
City
Elsenfeld
ZIP/Postal Code
63820
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel
City
Essen
ZIP/Postal Code
45127
Country
Germany
Facility Name
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Dialysezentrum
City
Freiburg
ZIP/Postal Code
79110
Country
Germany
Facility Name
KfH Kuratorium für Dialyse und Nierentransplantation e.V
City
Fürstenzell
ZIP/Postal Code
94081
Country
Germany
Facility Name
KfH Kuratorium für Dialyse und Nierentransplantation e.V
City
Gummersbach
ZIP/Postal Code
51643
Country
Germany
Facility Name
Dialyse Hamburg Barmbek
City
Hamburg
ZIP/Postal Code
22297
Country
Germany
Facility Name
Dialysepraxis Dr. Spengler
City
Helmstedt
ZIP/Postal Code
38350
Country
Germany
Facility Name
Marienhospital Herne
City
Herne
ZIP/Postal Code
44625
Country
Germany
Facility Name
Dialyse-Zentrum Elsterland
City
Herzberg
ZIP/Postal Code
04916
Country
Germany
Facility Name
Praxis Dr. Menzer
City
Homberg/Efze
ZIP/Postal Code
34576
Country
Germany
Facility Name
Nephrologische Praxis
City
Höchstadt
ZIP/Postal Code
91315
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Kamp-Lintfort
ZIP/Postal Code
47475
Country
Germany
Facility Name
KfH Nierenzentrum
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Dialysepraxis
City
Lahr
ZIP/Postal Code
77933
Country
Germany
Facility Name
Praxis für Innere Medizin und Nephrologie
City
Leverkusen
ZIP/Postal Code
51373
Country
Germany
Facility Name
Nephrologisches Zentrum Emsland
City
Lingen
ZIP/Postal Code
49808
Country
Germany
Facility Name
Dialysezentrum und Schwerpunktpraxis für Nieren- und Hochdruckerkrankungen
City
Mannheim
ZIP/Postal Code
68309
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Mayen
ZIP/Postal Code
56727
Country
Germany
Facility Name
Nephrologisches Zentrum Mettmann
City
Mettmann
ZIP/Postal Code
40822
Country
Germany
Facility Name
KfH Kuratorium für Nierentranplantation und Dialyse e.V.
City
Oberschleißheim
ZIP/Postal Code
85764
Country
Germany
Facility Name
Nierenzentrum Prenzlau
City
Prenzlau
ZIP/Postal Code
17291
Country
Germany
Facility Name
Nephrologische Ambulanz/ Dialyse
City
Singen
ZIP/Postal Code
78224
Country
Germany
Facility Name
KfH Kuratorium für Dialyse und Nierentransplantation e.V
City
Straubing
ZIP/Postal Code
94315
Country
Germany
Facility Name
Nieren- und Diabeteszentrum Viersen-Nettetal
City
Viersen-Dülken
ZIP/Postal Code
41751
Country
Germany
Facility Name
IRCCS INRCA Sede de Ancona
City
Ancona
ZIP/Postal Code
60100
Country
Italy
Facility Name
Ospedali Riuniti di Anzio e Nettuno
City
Anzio
ZIP/Postal Code
00042
Country
Italy
Facility Name
U.O.C. Nefrologia e Dialisi, C.G. Mazzoni
City
Ascoli Piceno
ZIP/Postal Code
63100
Country
Italy
Facility Name
Ospedaliero Universitaria Policlinico S. Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospdealiero "Istituti Ospitalieri"
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Ospedale E. Profili di Fabriano
City
Fabriano
ZIP/Postal Code
60044
Country
Italy
Facility Name
AO Universitaria Ospedali Riuniti
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Universitaria Degli Studi di Genova Clinica Nefrologica, Dialisi e Trapianto
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale A. Manzoni
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Azienda Ospedaliera Carlo Poma di Mantova
City
Mantova
ZIP/Postal Code
46100
Country
Italy
Facility Name
Azienda Ospedaliera Ospedale San Carlo Borromeo
City
Milano
ZIP/Postal Code
20153
Country
Italy
Facility Name
Azienda Ospedaliera Ospedale Niguarda Ca Granda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
AO Universitaria di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Ospedale Maggiore di Modica
City
Modica
ZIP/Postal Code
97015
Country
Italy
Facility Name
U.O. Nefrologia e Dialisi, P.O. Ospedale Casati, Centro Dialisi
City
Passirana di Rho
ZIP/Postal Code
20017
Country
Italy
Facility Name
Fondazione S. Maugeri
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliera ospedale S. Salvatore
City
Pesaro
ZIP/Postal Code
61100
Country
Italy
Facility Name
Ospedale A. Landolfi
City
Solofra
ZIP/Postal Code
83029
Country
Italy
Facility Name
Azienda Ospedaliera CTO - Maria Adelaide
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale San Giovanni Bosco
City
Torino
ZIP/Postal Code
10154
Country
Italy
Facility Name
Ospedale di Trento / Santa Chiara
City
Trento
ZIP/Postal Code
38100
Country
Italy
Facility Name
Ospedale dell'Angelo
City
Venezia Mestre
ZIP/Postal Code
30173
Country
Italy
Facility Name
PHO Clinical Hospital Dr. Trifun Panovski
City
Bitola
ZIP/Postal Code
7000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
PHO Health organisation Goce Delcev
City
Delcevo
ZIP/Postal Code
2320
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
PHO General Hospital Kocani
City
Kocani
ZIP/Postal Code
2300
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
PHO General Hospital Borka Taleski
City
Prilep
ZIP/Postal Code
7500
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
PHO Clinic of Nephrology
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
PHO General Hospital Stip
City
Stip
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Institute of Nephrology
City
Struga
ZIP/Postal Code
6330
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
PHO Medical Center Veles
City
Veles
ZIP/Postal Code
1400
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Specjalistyczny Szpital Wojewodzki w Ciechanowie
City
Ciechanow
ZIP/Postal Code
06-400
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. Najswietszej maryi Panny
City
Czestochowa
ZIP/Postal Code
42-200
Country
Poland
Facility Name
Samodzielnym Publicznym Zakladzie Opieki Zdrowotnej Dzialdowo
City
Dzialdowo
ZIP/Postal Code
13-200
Country
Poland
Facility Name
Stacja Dializ w Garwolinie
City
Garwolin
ZIP/Postal Code
08-400
Country
Poland
Facility Name
Szpital Specjalistyczny Sw. W. Adalberta
City
Gdansk
ZIP/Postal Code
80-462
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej AVITUM
City
Golub-Dobrzyn
ZIP/Postal Code
87-400
Country
Poland
Facility Name
B. Braun AVITUM Poland Sp.
City
Legnica
ZIP/Postal Code
59-220
Country
Poland
Facility Name
SP Szpital Kliniczny im. Barlickiego
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 4
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej
City
Pabianice
ZIP/Postal Code
95-200
Country
Poland
Facility Name
Radomski Szpital Specjalistyszny im. Dr Tytusa Chalubinskiego
City
Radom
ZIP/Postal Code
26-610
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny nr 3
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
Facility Name
Szpital Powiatowy im. Lekarza Z. Koprowskiego
City
Warsaw
ZIP/Postal Code
08-300
Country
Poland
Facility Name
Szpital Bielanski Blok F
City
Warszawa
ZIP/Postal Code
01-809
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Spitalul Clinic Municipal
City
Arad
ZIP/Postal Code
310017
Country
Romania
Facility Name
Institutul Clinic Fundeni
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Spitalul Clinic de urgenta "Floreasca"
City
Bucharest
ZIP/Postal Code
14461
Country
Romania
Facility Name
Spitalul Universitar de Urgenta
City
Bucharest
ZIP/Postal Code
50098
Country
Romania
Facility Name
SC Renamed Nefrodial SRL
City
Oradea
ZIP/Postal Code
410562
Country
Romania
Facility Name
FGUZ Clinical hospital No. 83 of FMBA of Russia
City
Moscow
ZIP/Postal Code
115682
Country
Russian Federation
Facility Name
City Clinal Hospital # 34
City
Novosibirsk
ZIP/Postal Code
630120
Country
Russian Federation
Facility Name
MLPU "Clinical City Hospital # 1"
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
GUZ "Yaroslavl regional clinical hospital"
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Oblasna klinichna likarnia imeni I.I.Mechnikova
City
Dnipropetrovsk
ZIP/Postal Code
49000
Country
Ukraine
Facility Name
Oblasnyi tsentr urologii ta nefrologii
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Tsentralnyi miskyi klinichnyi hospital, Viddilennia gemodializu
City
Kyiv
ZIP/Postal Code
01023
Country
Ukraine
Facility Name
Miska klinichna likarnia#3, Miskyi nefrologichnyi tsentr
City
Kyiv
ZIP/Postal Code
02125
Country
Ukraine
Facility Name
Instytut nefrologii AMN Ukrainy viddil nefrologii ta dializu
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Mykolaivska Oblasna Klinichna Likarnia, Viddilennia Gemodializu
City
Mykolayiv
ZIP/Postal Code
54058
Country
Ukraine
Facility Name
Ternopilska Oblasna Klinichna Likarnia, Viddilennia Nefrologii ta Gemodializu
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Oblasna klinikchna likarnia, tsentr transplantologii ta gemodializu
City
Zaporizhzhya
ZIP/Postal Code
69050
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22732334
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs