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

Phase 4

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: HX575 recombinant human erythropoietin alfa

• Registration Number: NCT00632125
• Lead Sponsor: Sandoz

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.

Study Timeline

• Study First Submitted: 2008-02-29
• Study First Submitted QC: 2008-03-07
• Study First Posted: 2008-03-10
• Study Start: 2008-07
• Primary Completion: 2010-03
• Study Completion: 2010-09
• Results First Submitted: 2017-04-03
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-10
• Last Update Submitted: 2017-07-10
• Results First Posted: 2017-07-11
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1695

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HX575 epoetin alfa i.v.	HX575 recombinant human erythropoietin alfa	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.

Primary Outcome Measures

Name	Time	Method
Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects	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

Trial Locations

Locations (104)

Ternopilska Oblasna Klinichna Likarnia, Viddilennia Nefrologii ta Gemodializu; 🇺🇦 Ternopil, Ukraine

Landeskrankenhaus Feldkirch; 🇦🇹 Feldkirch, Austria

Universitätsklinik für Innere Medizin III; 🇦🇹 Wien, Austria

Multiprofile Hospital for Active Treatment Dr. Kiro Popov; 🇧🇬 Karlovo, Bulgaria

CHG Hopital Yves le Foll; 🇫🇷 St Brieuc, France

KfH Kuratorium für Nierentranplantation und Dialyse e.V.; 🇩🇪 Oberschleißheim, Germany

Fachpraxis für Nieren und Hochdruckerkrankungen; 🇩🇪 Andernach, Germany

Gemeinschaftspraxis; 🇩🇪 Mayen, Germany

Kuratorium ür Dialyse und Nierentransplantation e.V.; 🇩🇪 Bayreuth, Germany

KfH Nierenzentrum; 🇩🇪 Köln, Germany

Alwall Praxis für Nieren- und Hochdruckkrankheiten; 🇩🇪 Berlin, Germany

Dialysepraxis; 🇩🇪 Lahr, Germany

Dialysepraxis Drs. Riedasch/Schreiber; 🇩🇪 Coesfeld, Germany

Facharzt für Innere Medizin und Nephrologie, Dialyse Centrum; 🇩🇪 Darmstadt, Germany

Dialysezentrum; 🇩🇪 Freiburg, Germany

Diabetes- und Dialysezentrum Merker, Vogt; 🇩🇪 Dormagen, Germany

Kuratorium für Dialyse und Nierentransplantation e.V.; 🇩🇪 Ehingen, Germany

Gemeinschaftspraxis Karlstraße; 🇩🇪 Düsseldorf, Germany

Dialysezentrum Elsenfeld; 🇩🇪 Elsenfeld, Germany

Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel; 🇩🇪 Essen, Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V.; 🇩🇪 Essen, Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V; 🇩🇪 Straubing, Germany

Dialyse Hamburg Barmbek; 🇩🇪 Hamburg, Germany

Dialysepraxis Dr. Spengler; 🇩🇪 Helmstedt, Germany

Marienhospital Herne; 🇩🇪 Herne, Germany

Dialyse-Zentrum Elsterland; 🇩🇪 Herzberg, Germany

Praxis Dr. Menzer; 🇩🇪 Homberg/Efze, Germany

Nephrologische Praxis; 🇩🇪 Höchstadt, Germany

Praxis für Innere Medizin und Nephrologie; 🇩🇪 Leverkusen, Germany

Nephrologisches Zentrum Emsland; 🇩🇪 Lingen, Germany

Nephrologisches Zentrum Mettmann; 🇩🇪 Mettmann, Germany

Dialysezentrum und Schwerpunktpraxis für Nieren- und Hochdruckerkrankungen; 🇩🇪 Mannheim, Germany

Nierenzentrum Prenzlau; 🇩🇪 Prenzlau, Germany

Nephrologische Ambulanz/ Dialyse; 🇩🇪 Singen, Germany

IRCCS INRCA Sede de Ancona; 🇮🇹 Ancona, Italy

Nieren- und Diabeteszentrum Viersen-Nettetal; 🇩🇪 Viersen-Dülken, Germany

Ospedali Riuniti di Anzio e Nettuno; 🇮🇹 Anzio, Italy

U.O.C. Nefrologia e Dialisi, C.G. Mazzoni; 🇮🇹 Ascoli Piceno, Italy

Ospedaliero Universitaria Policlinico S. Orsola Malpighi; 🇮🇹 Bologna, Italy

Azienda Ospdealiero "Istituti Ospitalieri"; 🇮🇹 Cremona, Italy

Ospedale E. Profili di Fabriano; 🇮🇹 Fabriano, Italy

AO Universitaria Ospedali Riuniti; 🇮🇹 Foggia, Italy

Universitaria Degli Studi di Genova Clinica Nefrologica, Dialisi e Trapianto; 🇮🇹 Genova, Italy

Ospedale A. Manzoni; 🇮🇹 Lecco, Italy

Azienda Ospedaliera Carlo Poma di Mantova; 🇮🇹 Mantova, Italy

Azienda Ospedaliera Ospedale San Carlo Borromeo; 🇮🇹 Milano, Italy

Azienda Ospedaliera Ospedale Niguarda Ca Granda; 🇮🇹 Milano, Italy

AO Universitaria di Modena; 🇮🇹 Modena, Italy

Ospedale Maggiore di Modica; 🇮🇹 Modica, Italy

Ospedale A. Landolfi; 🇮🇹 Solofra, Italy

U.O. Nefrologia e Dialisi, P.O. Ospedale Casati, Centro Dialisi; 🇮🇹 Passirana di Rho, Italy

Fondazione S. Maugeri; 🇮🇹 Pavia, Italy

Azienda Ospedaliera CTO - Maria Adelaide; 🇮🇹 Torino, Italy

Azienda Ospedaliera ospedale S. Salvatore; 🇮🇹 Pesaro, Italy

Ospedale San Giovanni Bosco; 🇮🇹 Torino, Italy

Ospedale di Trento / Santa Chiara; 🇮🇹 Trento, Italy

Ospedale dell'Angelo; 🇮🇹 Venezia Mestre, Italy

PHO Health organisation Goce Delcev; 🇲🇰 Delcevo, Macedonia, The Former Yugoslav Republic of

PHO Clinical Hospital Dr. Trifun Panovski; 🇲🇰 Bitola, Macedonia, The Former Yugoslav Republic of

PHO General Hospital Kocani; 🇲🇰 Kocani, Macedonia, The Former Yugoslav Republic of

PHO Clinic of Nephrology; 🇲🇰 Skopje, Macedonia, The Former Yugoslav Republic of

PHO General Hospital Borka Taleski; 🇲🇰 Prilep, Macedonia, The Former Yugoslav Republic of

Institute of Nephrology; 🇲🇰 Struga, Macedonia, The Former Yugoslav Republic of

PHO Medical Center Veles; 🇲🇰 Veles, Macedonia, The Former Yugoslav Republic of

PHO General Hospital Stip; 🇲🇰 Stip, Macedonia, The Former Yugoslav Republic of

Specjalistyczny Szpital Wojewodzki w Ciechanowie; 🇵🇱 Ciechanow, Poland

Samodzielnym Publicznym Zakladzie Opieki Zdrowotnej Dzialdowo; 🇵🇱 Dzialdowo, Poland

Stacja Dializ w Garwolinie; 🇵🇱 Garwolin, Poland

Samodzielny Publiczny Szpital Kliniczny nr 4; 🇵🇱 Lublin, Poland

SP Szpital Kliniczny im. Barlickiego; 🇵🇱 Lodz, Poland

Niepubliczny Zaklad Opieki Zdrowotnej; 🇵🇱 Pabianice, Poland

Szpital Bielanski Blok F; 🇵🇱 Warszawa, Poland

Szpital Powiatowy im. Lekarza Z. Koprowskiego; 🇵🇱 Warsaw, Poland

Spitalul Clinic de urgenta "Floreasca"; 🇷🇴 Bucharest, Romania

Spitalul Universitar de Urgenta; 🇷🇴 Bucharest, Romania

MLPU "Clinical City Hospital # 1"; 🇷🇺 Smolensk, Russian Federation

Oblasnyi tsentr urologii ta nefrologii; 🇺🇦 Kharkiv, Ukraine

Miska klinichna likarnia#3, Miskyi nefrologichnyi tsentr; 🇺🇦 Kyiv, Ukraine

Oblasna klinichna likarnia imeni I.I.Mechnikova; 🇺🇦 Dnipropetrovsk, Ukraine

Tsentralnyi miskyi klinichnyi hospital, Viddilennia gemodializu; 🇺🇦 Kyiv, Ukraine

Mykolaivska Oblasna Klinichna Likarnia, Viddilennia Gemodializu; 🇺🇦 Mykolayiv, Ukraine

Oblasna klinikchna likarnia, tsentr transplantologii ta gemodializu; 🇺🇦 Zaporizhzhya, Ukraine

Landeskrankenhaus Freistadt; 🇦🇹 Freistadt, Austria

LKH Rohrbach; 🇦🇹 Rohrbach, Austria

Multiprofile Hospital for Active Treatment Dr. Tota Venkova; 🇧🇬 Gabrovo, Bulgaria

Multiprofile Hospital for Active Treatment Pazardzhik; 🇧🇬 Pazardzhik, Bulgaria

Dialysepraxis Dres. Huspek/Schmid; 🇦🇹 Bad Ischl, Austria

Multiprofile Hospital for Active Treatment Rousse; 🇧🇬 Rousse, Bulgaria

Multiprofile Hospital for Active Treatment Sv. Ivan Rilski; 🇧🇬 Sofia, Bulgaria

Ministry of Interior-Central Clinical Base; 🇧🇬 Sofia, Bulgaria

Wojewodzki Szpital Specjalistyczny im. Najswietszej maryi Panny; 🇵🇱 Czestochowa, Poland

Szpital Specjalistyczny Sw. W. Adalberta; 🇵🇱 Gdansk, Poland

Radomski Szpital Specjalistyszny im. Dr Tytusa Chalubinskiego; 🇵🇱 Radom, Poland

Niepubliczny Zaklad Opieki Zdrowotnej AVITUM; 🇵🇱 Golub-Dobrzyn, Poland

B. Braun AVITUM Poland Sp.; 🇵🇱 Legnica, Poland

Wojewodzki Szpital Specjalistyczny nr 3; 🇵🇱 Rybnik, Poland

Centralny Szpital Kliniczny MSWiA; 🇵🇱 Warszawa, Poland

Spitalul Clinic Municipal; 🇷🇴 Arad, Romania

Institutul Clinic Fundeni; 🇷🇴 Bucharest, Romania

SC Renamed Nefrodial SRL; 🇷🇴 Oradea, Romania

City Clinal Hospital # 34; 🇷🇺 Novosibirsk, Russian Federation

GUZ "Yaroslavl regional clinical hospital"; 🇷🇺 Yaroslavl, Russian Federation

FGUZ Clinical hospital No. 83 of FMBA of Russia; 🇷🇺 Moscow, Russian Federation

Instytut nefrologii AMN Ukrainy viddil nefrologii ta dializu; 🇺🇦 Kyiv, Ukraine