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

July 10, 2017 updated by: Sandoz

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1695

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HX575 epoetin alfa i.v.
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.
Drug: HX575 recombinant human erythropoietin alfa
HX575 epoetin alfa i.v. will be administered according to the SmPC
Other Names:
  • HX575 epoetin alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Collaborators

Hexal AG

Investigators

  • Study Chair: Karsten Roth, Dr, Hexal AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

February 29, 2008

First Submitted That Met QC Criteria

March 7, 2008

First Posted (Estimate)

March 10, 2008

Study Record Updates

Last Update Posted (Actual)

July 11, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-66-INJ-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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