Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity of Subcutaneous EPO HEXAL vs. ERYPO® in the Treatment of Anemia Associated With Chronic Renal Insufficiency in Predialysis Patients

PHASE3TerminatedINTERVENTIONAL
Enrollment

337

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

July 31, 2009

Study Completion Date

January 31, 2010

Conditions
AnemiaChronic Renal Insufficiency
Interventions
DRUG

HX575 recombinant human erythropoietin alfa

Solution for injection (s.c.)

DRUG

ERYPO

Solution for injection (s.c.)

Trial Locations (123)

1030

Krankenanstalt der Stadt Wien, Vienna

1090

AKH Wien, Vienna

1220

Sozialmedizinisches Zentrum Ost Donauspital, Vienna

1431

MHAT Sveti Ivan Rilski, Sofia

4400

LKH Steyr, Steyr

MHAT Pazardijk, Pazardzhik

5020

Diakonissen KH Salzburg, Salzburg

6003

MHAT Stara Zagora, Stara Zagora

9002

"MHAT Sv. Anna", Varna

14021

IKEM, Prague

14612

Praxis Dr. Lüdemann, Falkensee

15006

FN Motol, Prague

16225

KfH Kuratorium f. Dialyse und Nierentransplantation e.V., Eberswalde

17109

Praxis Dr. Kraatz, Demmin

22297

Dialysepraxis Barmbek, Hamburg

27259

Nemocnice Kladno, Kladno

31848

Nephrologische Praxis Bad Münder, Bad Münder am Deister

34537

Nephrologisches Zentrum an Stadtkrankenhaus, Bad Wildungen

34576

Dialysezentrum, Homberg (Efze)

35043

Praxis Dr. Schütterle, Marburg

36266

KfH Kuratorium für Dialyse und Nierentransplantation e.V., Heringen

40210

Gemeinschaftspraxis Karlstraße, Düsseldorf

40211

Dialysepraxis Häger, Schanze, Brause, Düsseldorf

41100

NZOZ NEFROLUX Sp. J. Lucjan Sobieraj, Wojciech Kaminski, Siemianowice Śląskie

41334

Dialyse Nettetal, Nettetal

41539

Diabetes- und Dialysezentrum Merker, Vogt, Dormagen

42200

SP ZOZ Miejski Szpital Zespolony, Częstochowa

42653

Klinik für Nephrologie und Allgemeine Innere Medizin, Solingen

44866

Nephrologische Gemeinschaftspraxis Dr. Rensinghoff & Dr. Becker, Wattenscheid

45127

Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel, Essen

45136

Praxis Dr. Zimmermann, Essen

47798

Dialyseplaxis DR. Rieck, DR. Göbel, DR. Wagner, Krefeld

48145

Praxis Dr. Rose, Pohlmeier und Dr. Lammers, Münster

48653

Dialysepraxis drs. Riedasch/Schreiber, Coesfeld

50354

Gemeinschaftspraxis und Dialyse, Hürth

51373

GDG Gemeinnützige Dialyse Gesellschaft, Leverkusen

51465

KfH Kuratorium f. Dialyse und Nierentransplantation e.V., Bergisch Gladbach

54470

Schwerpunktpraxis für Diabetologie und Nephrologie, Bernkastel-Kues

55232

Gesundheitszentrum Alzey, Alzey

57014

Litomyslska nemocnice, a.s., Litomyšl

61500

Ambulance vnitrního lékarstvi, Brno

63739

Studienzentrum Hämatologie / Onkologie / Diabetes, Aschaffenburg

63741

Gemeinschaftspraxis Dr. med. Gert-Peter Dragoun, Dr. med Günther Hevendehl, Aschaffenburg

67059

KfH Kuratorium für Dialyse und Nierentransplantation e.V., Ludwigshafen

68309

Gemeinschaftspraxis Dres. Leistikow, Hafezi und Sandner, Mannheim

76230

CHU de Rouen - Hopital de Bois Guillaume, Bois-Guillaume

78054

Praxis Dr. med. Mauersberger, Villingen-Schwenningen

78501

Nemocnice Šternberk, Sternberk

79604

Nemocnice Prostìjov, Prostìjov

80054

CHU d'Amiens - Hopital Sud, Amiens

83435

Praxis Dr. Scharla, Bad Reichenhall

86720

KfH Kuratorium für dialyse und Nierentransplantation e.V., Nördlingen

91438

Dialyse-Centrum, Bad Windsheim

91550

Gemeinschaftspraxis Dr. Steffen & Dr. Perino, Dinkelsbühl

94032

KfH Kuratorium für Dialyse und Nierentransplantation e.V., Passau

94081

KfH Kuratorium für Dialyse und Nierentransplantation e.V., Fürstenzell

94315

KfH Kuratorium für Dialyse und Nierentransplantation e.V., Straubing

97437

KfH Kuratorium für Dialyse und Nierentransplantation e.V., Haßfurt

99610

Gemeinschaftspraxis Dr. Kirchner und Dr. Menge, Sömmerda

99894

Dialysepraxis, Friedrichroda

105203

"Federal State Institution National Medical Surgery center named after NI Pirogov of Federal Agency of Health Care and Social Development", Moscow

109240

"State Educational Institution of Higher Professional Education Moscow State University of Medicine and dentistry of Federal Agency of health Care and Social Development, City Clinical Hospital #23", Moscow

115432

Russian University of Peoples Frienship (clinical base: City clinical hospital #53), Moscow

125284

State Health Care Institution City Clinical Hospital named after SP Botkin, Moscow

150010

"Municipal Healthcare Institution City Clinical Hospital #2", Yaroslavl

150062

"State Healthcare Institution of Yaroslavl region Regional Clinical Hosptal", Yaroslavl

185019

"State Healthcare Institution Reoublic Hospital named after VA Baranov", Petrozavodsk

191015

"State Educational Institution of Higher Professional Education St. Petersburg State Medical Academy for Postgraduate studies of Roszdrav", Saint Petersburg

191104

"St. Petersburg State Healthcare Institution City Mariinsky Hospital", Saint Petersburg

192242

"State Institution St. petersburg Clinical research Institute of Emergency Medical Care named after I.I. Dzhanelidze", Saint Petersburg

194358

"St. Petersburg State Healthcare Institution City Outpatient Clinic #17", Saint Petersburg

195067

"State Educational Institution of Higher Professional Education St. Petersburg State Medical Academy named after I.I. Mechnikov of Roszdrav", Saint Petersburg

State Institute St. Petersburg, Saint Petersburg

197022

"State Educational Institution of Higher Professional Education St. Petersburg State Medical Institute named after IP Pavlov of Roszdrav", Saint Petersburg

214018

"State Educational Institution of Higher Professional Education Smolensk State Medical Academy of Federal Agency of Health Care and Social Development", Smolensk

300359

SC Medicali's SRL, Timișoara

300736

Emergency Clinical County Hospital, Timișoara

Spitalul Judetean Timisoara, Timișoara

300766

Policlinica Dr. Citu, Timișoara

302004

Monilek Hospital and Research Center, Jaipur

330084

County Hospital Deva, Deva

357538

"Municipal healthcare Institution City Clinical Hospital #2", Pyatigorsk

390026

"State Healthcare Institution Ryazan Regional Cardiological Dispensary", Ryazan

410053

State Educational Institution of High Professional Education Saratov State Medical University of Roszdrav, Saratov

410469

Dr. Gavril Curteanu Clinical Hospital, Oradea

411001

Pulse Diagnostix Cardiac and Medical Center, Pune

452010

Bombay Hospital, Indore

500068

Kamineni Hospitals Ltd., Hyderabaad

500082

NIZAM Institute of Medical Sciences, Hyderabaad

540103

County Hospital Tg Mures, Tg Mures

575003

Vinaya Hospital & Research Centre, Mangalore

603126

"State healthcare Institution Nizhegorodsky Regional Clinical Hospital named after NA Semashko", Nizhny Novgorod

620102

"Municipal Institution City Clinical Hospital #40", Yekaterinburg

"State Healthcare Institution Sverdlovsk Regional Clinical Hospital #1", Yekaterinburg

634012

State Institution Scientific Research Institute of Cardiology of Tomsk Research Center of Siberian Branch of Russian Academy of Medical Sciences, Tomsk

634041

SibMedCenter LLC, Tomsk

650066

"State Healthcare Institution Kemerova Regional Clinical Hospital", Kemerovo

656099

"Municipal medical Institution City Hospital #1", Barnaul

695029

Kerala Institute of Medical Sciences, Trivandrum

700503

Spitalul Clinic CI Parhon Iasi, Iași

741 01

Nemocnice s poliklinikou v Novem Jicine, Novi Jicin

140 00

Dialcorp, s.r.o., Praha 4 - Michle

591 01

Nefrologická a interní amb., Žïár N. Sázavou

01877

KfH Kuratorium für Dialyse und Nierentransplantation e.V., Bischofswerda

04103

Leipziger Institut für Präventivmedizin, Leipzig

04107

Med Center Leipzig, Leipzig

09648

Praxis Dr. Vogel-Wagner, Mittweida

01796

Praxis Dipl. med. Kosch, Pirna

06484

Dialysepraxis Dipl. med. Gierak & Dipl. med. Rettig, Quedlinburg

60-479

Szpital Wojewódzki w Poznaniu, Poznan

60-539

Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwor (Solumed SC), Poznan

09-402

Specjalistyczna Przychodnia Lekarska Medikard, Płock

43-100

Wojewodzki Szpital Specjalistyczny nr. 1 im. Jozefa Gasinskiego, Tychy

03401

Szpital Praski p.w. Przemienienia Panskiego II Oddzia Chorob Wewnetrznych, Warsaw

50-349

NZOZ Centrum Badan Klinicznych, Wroclaw

011794

Centrul Medical de Diagnostic si Tratament Ambulator si Medicina Preventiva Bucuresti, Bucharest

020475

Institutul National de DiabetNutritie si Boli Metabolice Paulescu, Bucharest

022328

Institutul Clinic Fundeni, Bucharest

050098

Spitalul Universitar Bucuresti, Bucharest

400 006

Spitalul Clinic Judetean Cluj, Cluj-Napoca

040 01

MEDIKOL s.r.o., Košice

04001

SMOLKO s.r.o., Košice

917 75

FN Trnava, Trnava

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sandoz

INDUSTRY