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

Chronic Kidney Disease Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632125
• Other study ID #: 2006-66-INJ-14
• Status: Completed
• Phase: Phase 4
• First received: February 29, 2008
• Last updated: July 10, 2017
• Start date: July 2008
• Est. completion date: September 2010

Study information

• Verified date: July 2017
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1695
• Est. completion date: September 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• HX575 recombinant human erythropoietin alfa
HX575 epoetin alfa i.v. will be administered according to the SmPC

Locations

Country	Name	City	State
Austria	Dialysepraxis Dres. Huspek/Schmid	Bad Ischl
Austria	Landeskrankenhaus Feldkirch	Feldkirch
Austria	Landeskrankenhaus Freistadt	Freistadt
Austria	LKH Rohrbach	Rohrbach
Austria	Universitätsklinik für Innere Medizin III	Wien
Bulgaria	Multiprofile Hospital for Active Treatment Dr. Tota Venkova	Gabrovo
Bulgaria	Multiprofile Hospital for Active Treatment Dr. Kiro Popov	Karlovo
Bulgaria	Multiprofile Hospital for Active Treatment Pazardzhik	Pazardzhik
Bulgaria	Multiprofile Hospital for Active Treatment Rousse	Rousse
Bulgaria	Ministry of Interior-Central Clinical Base	Sofia
Bulgaria	Multiprofile Hospital for Active Treatment Sv. Ivan Rilski	Sofia
France	CHG Hopital Yves le Foll	St Brieuc
Germany	Fachpraxis für Nieren und Hochdruckerkrankungen	Andernach
Germany	KfH Kuratorium für Nierentranplantation und Dialyse e.V.	Aschaffenburg
Germany	Gemeinschaftspraxis	Baunatal
Germany	Kuratorium ür Dialyse und Nierentransplantation e.V.	Bayreuth
Germany	Alwall Praxis für Nieren- und Hochdruckkrankheiten	Berlin
Germany	KfH Nierenzentrum	Berlin
Germany	Dialysepraxis	Bremerhaven
Germany	Dialysepraxis Drs. Riedasch/Schreiber	Coesfeld
Germany	Facharzt für Innere Medizin und Nephrologie, Dialyse Centrum	Darmstadt
Germany	KfH Kuratorium für Nierentranplantation und Dialyse e.V.	Deggendorf
Germany	Dialysezentrum	Dinkelsbühl
Germany	Diabetes- und Dialysezentrum Merker, Vogt	Dormagen
Germany	KfH Nierenzentrum	Dortmund
Germany	Gemeinschaftspraxis Karlstraße	Düsseldorf
Germany	Kuratorium für Dialyse und Nierentransplantation e.V.	Ehingen
Germany	Dialysezentrum Elsenfeld	Elsenfeld
Germany	Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel	Essen
Germany	KfH Kuratorium für Dialyse und Nierentransplantation e.V.	Essen
Germany	Dialysezentrum	Freiburg
Germany	KfH Kuratorium für Dialyse und Nierentransplantation e.V	Fürstenzell
Germany	KfH Kuratorium für Dialyse und Nierentransplantation e.V	Gummersbach
Germany	Dialyse Hamburg Barmbek	Hamburg
Germany	Dialysepraxis Dr. Spengler	Helmstedt
Germany	Marienhospital Herne	Herne
Germany	Dialyse-Zentrum Elsterland	Herzberg
Germany	Nephrologische Praxis	Höchstadt
Germany	Praxis Dr. Menzer	Homberg/Efze
Germany	Gemeinschaftspraxis	Kamp-Lintfort
Germany	KfH Nierenzentrum	Köln
Germany	Dialysepraxis	Lahr
Germany	Praxis für Innere Medizin und Nephrologie	Leverkusen
Germany	Nephrologisches Zentrum Emsland	Lingen
Germany	Dialysezentrum und Schwerpunktpraxis für Nieren- und Hochdruckerkrankungen	Mannheim
Germany	Gemeinschaftspraxis	Mayen
Germany	Nephrologisches Zentrum Mettmann	Mettmann
Germany	KfH Kuratorium für Nierentranplantation und Dialyse e.V.	Oberschleißheim
Germany	Nierenzentrum Prenzlau	Prenzlau
Germany	Nephrologische Ambulanz/ Dialyse	Singen
Germany	KfH Kuratorium für Dialyse und Nierentransplantation e.V	Straubing
Germany	Nieren- und Diabeteszentrum Viersen-Nettetal	Viersen-Dülken
Italy	IRCCS INRCA Sede de Ancona	Ancona
Italy	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 Niguarda Ca Granda	Milano
Italy	Azienda Ospedaliera Ospedale San Carlo Borromeo	Milano
Italy	AO Universitaria di Modena	Modena
Italy	Ospedale Maggiore di Modica	Modica
Italy	U.O. Nefrologia e Dialisi, P.O. Ospedale Casati, Centro Dialisi	Passirana di Rho
Italy	Fondazione S. Maugeri	Pavia
Italy	Azienda Ospedaliera ospedale S. Salvatore	Pesaro
Italy	Ospedale A. Landolfi	Solofra
Italy	Azienda Ospedaliera CTO - Maria Adelaide	Torino
Italy	Ospedale San Giovanni Bosco	Torino
Italy	Ospedale di Trento / Santa Chiara	Trento
Italy	Ospedale dell'Angelo	Venezia Mestre
Macedonia, The Former Yugoslav Republic of	PHO Clinical Hospital Dr. Trifun Panovski	Bitola
Macedonia, The Former Yugoslav Republic of	PHO Health organisation Goce Delcev	Delcevo
Macedonia, The Former Yugoslav Republic of	PHO General Hospital Kocani	Kocani
Macedonia, The Former Yugoslav Republic of	PHO General Hospital Borka Taleski	Prilep
Macedonia, The Former Yugoslav Republic of	PHO Clinic of Nephrology	Skopje
Macedonia, The Former Yugoslav Republic of	PHO General Hospital Stip	Stip
Macedonia, The Former Yugoslav Republic of	Institute of Nephrology	Struga
Macedonia, The Former Yugoslav Republic of	PHO Medical Center Veles	Veles
Poland	Specjalistyczny Szpital Wojewodzki w Ciechanowie	Ciechanow
Poland	Wojewodzki Szpital Specjalistyczny im. Najswietszej maryi Panny	Czestochowa
Poland	Samodzielnym Publicznym Zakladzie Opieki Zdrowotnej Dzialdowo	Dzialdowo
Poland	Stacja Dializ w Garwolinie	Garwolin
Poland	Szpital Specjalistyczny Sw. W. Adalberta	Gdansk
Poland	Niepubliczny Zaklad Opieki Zdrowotnej AVITUM	Golub-Dobrzyn
Poland	B. Braun AVITUM Poland Sp.	Legnica
Poland	SP Szpital Kliniczny im. Barlickiego	Lodz
Poland	Samodzielny Publiczny Szpital Kliniczny nr 4	Lublin
Poland	Niepubliczny Zaklad Opieki Zdrowotnej	Pabianice
Poland	Radomski Szpital Specjalistyszny im. Dr Tytusa Chalubinskiego	Radom
Poland	Wojewodzki Szpital Specjalistyczny nr 3	Rybnik
Poland	Szpital Powiatowy im. Lekarza Z. Koprowskiego	Warsaw
Poland	Centralny Szpital Kliniczny MSWiA	Warszawa
Poland	Szpital Bielanski Blok F	Warszawa
Romania	Spitalul Clinic Municipal	Arad
Romania	Institutul Clinic Fundeni	Bucharest
Romania	Spitalul Clinic de urgenta "Floreasca"	Bucharest
Romania	Spitalul Universitar de Urgenta	Bucharest
Romania	SC Renamed Nefrodial SRL	Oradea
Russian Federation	FGUZ Clinical hospital No. 83 of FMBA of Russia	Moscow
Russian Federation	City Clinal Hospital # 34	Novosibirsk
Russian Federation	MLPU "Clinical City Hospital # 1"	Smolensk
Russian Federation	GUZ "Yaroslavl regional clinical hospital"	Yaroslavl
Ukraine	Oblasna klinichna likarnia imeni I.I.Mechnikova	Dnipropetrovsk
Ukraine	Oblasnyi tsentr urologii ta nefrologii	Kharkiv
Ukraine	Instytut nefrologii AMN Ukrainy viddil nefrologii ta dializu	Kyiv
Ukraine	Miska klinichna likarnia#3, Miskyi nefrologichnyi tsentr	Kyiv
Ukraine	Tsentralnyi miskyi klinichnyi hospital, Viddilennia gemodializu	Kyiv
Ukraine	Mykolaivska Oblasna Klinichna Likarnia, Viddilennia Gemodializu	Mykolayiv
Ukraine	Ternopilska Oblasna Klinichna Likarnia, Viddilennia Nefrologii ta Gemodializu	Ternopil
Ukraine	Oblasna klinikchna likarnia, tsentr transplantologii ta gemodializu	Zaporizhzhya

Sponsors (2)

Lead Sponsor	Collaborator
Sandoz	Hexal AG

Countries where clinical trial is conducted

Austria,  Bulgaria,  France,  Germany,  Italy,  Macedonia, The Former Yugoslav Republic of,  Poland,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months