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Chronic Kidney DiseasePhase 4EPO-PASSNCT00632125

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

A Phase 4 study testing HX575 recombinant human erythropoietin alfa in people with Chronic Kidney Disease, run by Sandoz at 114 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Disease
What is being tested?
HX575 recombinant human erythropoietin alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,695 participants
Where
114 sitesin 10 countries
Study dates
Jul 2008to Sep 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 -

Who cannot join

  • 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.

Trial locations and contacts

114 sites in 10 countries.

114 sites in 10 countries

Germany40 sites

  • Fachpraxis für Nieren und Hochdruckerkrankungen

    Andernach, 56626

  • KfH Kuratorium für Nierentranplantation und Dialyse e.V.

    Aschaffenburg, 63741

  • Gemeinschaftspraxis

    Baunatal, 34225

  • Kuratorium ür Dialyse und Nierentransplantation e.V.

    Bayreuth, 95445

  • KfH Nierenzentrum

    Berlin, 12247

  • Alwall Praxis für Nieren- und Hochdruckkrankheiten

    Berlin, 13125

  • Dialysepraxis

    Bremerhaven, 27570

  • Dialysepraxis Drs. Riedasch/Schreiber

    Coesfeld, 48653

  • KfH Nierenzentrum

    Cologne, 50937

  • Facharzt für Innere Medizin und Nephrologie, Dialyse Centrum

    Darmstadt, 64295

  • KfH Kuratorium für Nierentranplantation und Dialyse e.V.

    Deggendorf, 94469

  • Dialysezentrum

    Dinkelsbühl, 91550

  • Diabetes- und Dialysezentrum Merker, Vogt

    Dormagen, 41539

  • KfH Nierenzentrum

    Dortmund, 44141

  • Gemeinschaftspraxis Karlstraße

    Düsseldorf, 40210

  • Kuratorium für Dialyse und Nierentransplantation e.V.

    Ehingen, 89584

  • Dialysezentrum Elsenfeld

    Elsenfeld, 63820

  • Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel

    Essen, 45127

  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.

    Essen, 45136

  • Dialysezentrum

    Freiburg im Breisgau, 79110

  • KfH Kuratorium für Dialyse und Nierentransplantation e.V

    Fürstenzell, 94081

  • KfH Kuratorium für Dialyse und Nierentransplantation e.V

    Gummersbach, 51643

  • Dialyse Hamburg Barmbek

    Hamburg, 22297

  • Dialysepraxis Dr. Spengler

    Helmstedt, 38350

  • Marienhospital Herne

    Herne, 44625

  • Dialyse-Zentrum Elsterland

    Herzberg, 04916

  • Nephrologische Praxis

    Höchstadt an der Aisch, 91315

  • Praxis Dr. Menzer

    Homberg (Efze), 34576

  • Gemeinschaftspraxis

    Kamp-Lintfort, 47475

  • Dialysepraxis

    Lahr, 77933

  • Praxis für Innere Medizin und Nephrologie

    Leverkusen, 51373

  • Nephrologisches Zentrum Emsland

    Lingen, 49808

  • Dialysezentrum und Schwerpunktpraxis für Nieren- und Hochdruckerkrankungen

    Mannheim, 68309

  • Gemeinschaftspraxis

    Mayen, 56727

  • Nephrologisches Zentrum Mettmann

    Mettmann, 40822

  • KfH Kuratorium für Nierentranplantation und Dialyse e.V.

    Oberschleißheim, 85764

  • Nierenzentrum Prenzlau

    Prenzlau, 17291

  • Nephrologische Ambulanz/ Dialyse

    Singen, 78224

  • KfH Kuratorium für Dialyse und Nierentransplantation e.V

    Straubing, 94315

  • Nieren- und Diabeteszentrum Viersen-Nettetal

    Viersen-Dülken, 41751

Other trials in Germany

Italy22 sites

  • IRCCS INRCA Sede de Ancona

    Ancona, 60100

  • Ospedali Riuniti di Anzio e Nettuno

    Anzio, 00042

  • U.O.C. Nefrologia e Dialisi, C.G. Mazzoni

    Ascoli Piceno, 63100

  • Ospedaliero Universitaria Policlinico S. Orsola Malpighi

    Bologna, 40138

  • Azienda Ospdealiero "Istituti Ospitalieri"

    Cremona, 26100

  • Ospedale E. Profili di Fabriano

    Fabriano, 60044

  • AO Universitaria Ospedali Riuniti

    Foggia, 71100

  • Universitaria Degli Studi di Genova Clinica Nefrologica, Dialisi e Trapianto

    Genova, 16132

  • Ospedale A. Manzoni

    Lecco, 23900

  • Azienda Ospedaliera Carlo Poma di Mantova

    Mantua, 46100

  • Azienda Ospedaliera Ospedale San Carlo Borromeo

    Milan, 20153

  • Azienda Ospedaliera Ospedale Niguarda Ca Granda

    Milan, 20162

  • AO Universitaria di Modena

    Modena, 41100

  • Ospedale Maggiore di Modica

    Modica, 97015

  • U.O. Nefrologia e Dialisi, P.O. Ospedale Casati, Centro Dialisi

    Passirana Di Rho, 20017

  • Fondazione S. Maugeri

    Pavia, 27100

  • Azienda Ospedaliera ospedale S. Salvatore

    Pesaro, 61100

  • Ospedale A. Landolfi

    Solofra, 83029

  • Azienda Ospedaliera CTO - Maria Adelaide

    Torino, 10126

  • Ospedale San Giovanni Bosco

    Torino, 10154

  • Ospedale di Trento / Santa Chiara

    Trento, 38100

  • Ospedale dell'Angelo

    Venezia Mestre, 30173

Other trials in Italy

Poland15 sites

  • Specjalistyczny Szpital Wojewodzki w Ciechanowie

    Ciechanów, 06-400

  • Wojewodzki Szpital Specjalistyczny im. Najswietszej maryi Panny

    Częstochowa, 42-200

  • Samodzielnym Publicznym Zakladzie Opieki Zdrowotnej Dzialdowo

    Działdowo, 13-200

  • Stacja Dializ w Garwolinie

    Garwolin, 08-400

  • Szpital Specjalistyczny Sw. W. Adalberta

    Gdansk, 80-462

  • Niepubliczny Zaklad Opieki Zdrowotnej AVITUM

    Golub-Dobrzyń, 87-400

  • B. Braun AVITUM Poland Sp.

    Legnica, 59-220

  • SP Szpital Kliniczny im. Barlickiego

    Lodz, 90-153

  • Samodzielny Publiczny Szpital Kliniczny nr 4

    Lublin, 20-954

  • Niepubliczny Zaklad Opieki Zdrowotnej

    Pabianice, 95-200

  • Radomski Szpital Specjalistyszny im. Dr Tytusa Chalubinskiego

    Radom, 26-610

  • Wojewodzki Szpital Specjalistyczny nr 3

    Rybnik, 44-200

  • Szpital Bielanski Blok F

    Warsaw, 01-809

  • Centralny Szpital Kliniczny MSWiA

    Warsaw, 02-507

  • Szpital Powiatowy im. Lekarza Z. Koprowskiego

    Warsaw, 08-300

Other trials in Poland

North Macedonia8 sites

  • PHO Clinical Hospital Dr. Trifun Panovski

    Bitola, 7000

  • PHO Health organisation Goce Delcev

    Delcevo, 2320

  • PHO General Hospital Kocani

    Kočani, 2300

  • PHO General Hospital Borka Taleski

    Prilep, 7500

  • PHO General Hospital Stip

    Shtip, 1000

  • PHO Clinic of Nephrology

    Skopje, 1000

  • Institute of Nephrology

    Struga, 6330

  • PHO Medical Center Veles

    Veles, 1400

Other trials in North Macedonia

Ukraine8 sites

  • Oblasna klinichna likarnia imeni I.I.Mechnikova

    Dnipropetrovsk, 49000

  • Oblasnyi tsentr urologii ta nefrologii

    Kharkiv, 61037

  • Tsentralnyi miskyi klinichnyi hospital, Viddilennia gemodializu

    Kyiv, 01023

  • Miska klinichna likarnia#3, Miskyi nefrologichnyi tsentr

    Kyiv, 02125

  • Instytut nefrologii AMN Ukrainy viddil nefrologii ta dializu

    Kyiv, 04050

  • Mykolaivska Oblasna Klinichna Likarnia, Viddilennia Gemodializu

    Mykolayiv, 54058

  • Ternopilska Oblasna Klinichna Likarnia, Viddilennia Nefrologii ta Gemodializu

    Ternopil, 46002

  • Oblasna klinikchna likarnia, tsentr transplantologii ta gemodializu

    Zaporizhzhya, 69050

Other trials in Ukraine

Bulgaria6 sites

  • Multiprofile Hospital for Active Treatment Dr. Tota Venkova

    Gabrovo, 5300

  • Multiprofile Hospital for Active Treatment Dr. Kiro Popov

    Karlovo, 4300

  • Multiprofile Hospital for Active Treatment Pazardzhik

    Pazardzhik, 40400

  • Multiprofile Hospital for Active Treatment Rousse

    Rousse, 7002

  • Multiprofile Hospital for Active Treatment Sv. Ivan Rilski

    Sofia, 1431

  • Ministry of Interior-Central Clinical Base

    Sofia, 1606

Other trials in Bulgaria

Austria5 sites

  • Dialysepraxis Dres. Huspek/Schmid

    Bad Ischl, 4820

  • Landeskrankenhaus Feldkirch

    Feldkirch, 6800

  • Landeskrankenhaus Freistadt

    Freistadt, 4240

  • LKH Rohrbach

    Rohrbach, 4150

  • Universitätsklinik für Innere Medizin III

    Vienna, 1090

Other trials in Austria

Romania5 sites

  • Spitalul Clinic Municipal

    Arad, 310017

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Spitalul Clinic de urgenta "Floreasca"

    Bucharest, 14461

  • Spitalul Universitar de Urgenta

    Bucharest, 50098

  • SC Renamed Nefrodial SRL

    Oradea, 410562

Other trials in Romania

Russia4 sites

  • FGUZ Clinical hospital No. 83 of FMBA of Russia

    Moscow, 115682

  • City Clinal Hospital # 34

    Novosibirsk, 630120

  • MLPU "Clinical City Hospital # 1"

    Smolensk, 214019

  • GUZ "Yaroslavl regional clinical hospital"

    Yaroslavl, 150062

Other trials in Russia

France1 site

  • CHG Hopital Yves le Foll

    Saint-Brieuc, 22023

Other trials in France

About this study

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.

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.

Read the 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.

Being tested
HX575 recombinant human erythropoietin alfa
Keywords
CKD subjects with or without dialysis treatment
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HX575 recombinant human erythropoietin alfaDrug

    Also called HX575 epoetin alfa

    HX575 epoetin alfa i.v. will be administered according to the SmPC

Study groups in NCT00632125
Study groupRoleWhat they receive
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.
Receives: Drug: HX575 recombinant human erythropoietin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionMar 2010
  4. Study completionSep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,695 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00632125
Sponsor's protocol ID
2006-66-INJ-14
Acronym
EPO-PASS
Status last verified
Jul 2017
First submitted
29 Feb 2008
Last updated
11 Jul 2017
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22732334

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing HX575 recombinant human erythropoietin alfa in people with Chronic Kidney Disease, run by Sandoz at 114 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in Germany, Italy, Poland, North Macedonia, Ukraine and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00632125, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.

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EPO-PASS Clinical Trial NCT00632125 | AzTrials