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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1695

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Cà 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sandoz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hexal AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 29, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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