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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

Primary Purpose

Anemia, Chronic Renal Insufficiency

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HX575 recombinant human erythropoietin alfa
ERYPO
Sponsored by
Sandoz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Treatment, associated, with CRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Known chronic renal insufficiency of at least 4 weeks duration; CKD stage at least 3 or higher
  • Male and female patients, age: >=18
  • Patients who are naïve to ESA treatment or previously ESA treated after 3 months of ESA-free period (i.v. or s.c.)
  • Patients with symptomatic anemia, defined as Hb level below 11.0 g/dL and not lower than or equal to 7.5 g/dL on at least 2 visits during the screening period
  • Adequate iron status, serum ferritin >= 100 µg/L or transferrin saturation >= 20%
  • Ability to follow study instructions and likely to complete all required visits and compliant with subcutaneous administration
  • Written informed consent of the patient.

Exclusion Criteria:

  • Anemia of non-renal causes
  • Therapy with immunosuppressants (other than corticosteroids for chronic treatment) within 3 months before screening and during the study for patients with renal allograft in place or other chronic conditions (e.g. lupus erythematosus, rheumatic arthritis)
  • Patients previously treated with chronic dialysis within the last 6 months (exception: one session of acute dialysis)
  • Patients with acute deterioration of renal function during the screening phase according to the investigator's judgment
  • Patients receiving any RBC/whole blood transfusion during the screening period
  • Primary hematological disorder (e.g. myeloma, myelodysplastic syndrome, sickle cell anemia, hematological malignancy, hemolytic anemia)
  • Evidence of uncontrolled diabetes mellitus (HbA1c > 10 % at visit -2)
  • Evidence of severe hepatic dysfunction (e.g. ALT and/or AST above 2x upper limit of normal range; or gamma-GT above 3x upper limit of normal range)
  • Clinical evidence of current uncontrolled or symptomatic hyperparathyroidism, defined as parathyroid hormone > 500 ng/L at visit -2.
  • Uncontrolled hypertension, defined as a systolic blood pressure of >= 160 mmHg and a diastolic blood pressure measurement >= 100 mmHg (average of two values with at least one day between measurements)
  • Congestive heart failure and/or angina pectoris [New York Heart Association (NYHA) class III and IV]
  • History of stroke or myocardial infarction during the last 6 months prior to visit -2
  • Ongoing treatment with phenprocoumon or other cumarin derivates
  • Thrombocytopenia (platelet count <100.000/µL) or leucopenia (white blood cell count < 2.000/µL)
  • Gastrointestinal bleeding within the last 6 months prior to visit -2 or hemolysis
  • Evidence of acute or chronic infection by a C-reactive protein value of > 30 mg/L
  • Suspicion or known PRCA (pure red cell aplasia)
  • Previously diagnosed HIV or acute hepatitis infection
  • History of epilepsy or epileptic seizures or treatment for epilepsy within the past 6 months prior to screening
  • Planned major surgery (with expected high blood loss) during the next 3 months or major surgery within the previous 3 months (except laser photocoagulation, access surgery)
  • Clinical evidence of active malignant diseases within the last 5 years (except non-melanoma skin cancer)
  • Pregnancy, breastfeeding women or women not using a highly effective birth control method (e.g. implants, injectables, combined oral contraceptives, IUD, sexual abstinence, vasectomised partner)
  • Known history of severe drug related allergies (e.g. anaphylactic shock)
  • Known allergy to one of the ingredients of the test product or hypersensitivity to mammalian-derived products
  • Known or suspicion of any non-compliance with respect to subcutaneous treatment
  • Simultaneous participation in another clinical study or participation in a study in the month preceding visit-2 or previously randomized in this study
  • Participation in another ESA study in the 3 months preceding visit -2
  • Any other condition which at the investigator's discretion may put the patient at risk or which may confound the study results.

Sites / Locations

  • Diakonissen KH Salzburg
  • LKH Steyr
  • Krankenanstalt der Stadt Wien
  • AKH Wien
  • Sozialmedizinisches Zentrum Ost Donauspital
  • MHAT Pazardijk
  • MHAT Sveti Ivan Rilski
  • MHAT Stara Zagora
  • MHAT "Sv. Anna"
  • Ambulance vnitrního lékarstvi
  • Nemocnice Kladno
  • Litomyslska nemocnice, a.s.
  • Nemocnice s poliklinikou v Novem Jicine
  • Dialcorp, s.r.o.
  • IKEM
  • FN Motol
  • Nemocnice Prostìjov
  • Nemocnice Šternberk
  • Nefrologická a interní amb.
  • CHU d'Amiens - Hopital Sud
  • CHU de Rouen - Hopital de Bois Guillaume
  • Gesundheitszentrum Alzey
  • Studienzentrum Hämatologie / Onkologie / Diabetes
  • Gemeinschaftspraxis Dr. med. Gert-Peter Dragoun, Dr. med Günther Hevendehl
  • Nephrologische Praxis Bad Münder
  • Praxis Dr. Scharla
  • Nephrologisches Zentrum an Stadtkrankenhaus
  • Dialyse-Centrum
  • KfH Kuratorium f. Dialyse und Nierentransplantation e.V.
  • Schwerpunktpraxis für Diabetologie und Nephrologie
  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.
  • Nephrologische Gemeinschaftspraxis Dr. Rensinghoff & Dr. Becker
  • Dialysepraxis drs. Riedasch/Schreiber
  • Praxis Dr. Kraatz
  • Gemeinschaftspraxis Dr. Steffen & Dr. Perino
  • Diabetes- und Dialysezentrum Merker, Vogt
  • Gemeinschaftspraxis Karlstraße
  • Dialysepraxis Häger, Schanze, Brause
  • KfH Kuratorium f. Dialyse und Nierentransplantation e.V.
  • Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel
  • Praxis Dr. Zimmermann
  • Praxis Dr. Lüdemann
  • Dialysepraxis
  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.
  • Dialysepraxis Barmbek
  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.
  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.
  • Dialysezentrum
  • Gemeinschaftspraxis und Dialyse
  • Dialyseplaxis DR. Rieck, DR. Göbel, DR. Wagner
  • Leipziger Institut für Präventivmedizin
  • Med Center Leipzig
  • GDG Gemeinnützige Dialyse Gesellschaft
  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.
  • Gemeinschaftspraxis Dres. Leistikow, Hafezi und Sandner
  • Praxis Dr. Schütterle
  • Praxis Dr. Vogel-Wagner
  • Praxis Dr. Rose, Pohlmeier und Dr. Lammers
  • Dialyse Nettetal
  • KfH Kuratorium für dialyse und Nierentransplantation e.V.
  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.
  • Praxis Dipl. med. Kosch
  • Dialysepraxis Dipl. med. Gierak & Dipl. med. Rettig
  • Klinik für Nephrologie und Allgemeine Innere Medizin
  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.
  • Gemeinschaftspraxis Dr. Kirchner und Dr. Menge
  • Praxis Dr. med. Mauersberger
  • Kamineni Hospitals Ltd.
  • NIZAM Institute of Medical Sciences
  • Bombay Hospital
  • Monilek Hospital and Research Center
  • Vinaya Hospital & Research Centre
  • Pulse Diagnostix Cardiac and Medical Center
  • Kerala Institute of Medical Sciences
  • SP ZOZ Miejski Szpital Zespolony
  • Specjalistyczna Przychodnia Lekarska Medikard
  • Szpital Wojewódzki w Poznaniu
  • Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwor (Solumed SC)
  • NZOZ NEFROLUX Sp. J. Lucjan Sobieraj, Wojciech Kaminski
  • Wojewodzki Szpital Specjalistyczny nr. 1 im. Jozefa Gasinskiego
  • Szpital Praski p.w. Przemienienia Panskiego II Oddzia Chorob Wewnetrznych
  • NZOZ Centrum Badan Klinicznych
  • Centrul Medical de Diagnostic si Tratament Ambulator si Medicina Preventiva Bucuresti
  • Institutul National de DiabetNutritie si Boli Metabolice Paulescu
  • Institutul Clinic Fundeni
  • Spitalul Universitar Bucuresti
  • Spitalul Clinic Judetean Cluj
  • County Hospital Deva
  • Spitalul Clinic CI Parhon Iasi
  • Dr. Gavril Curteanu Clinical Hospital
  • County Hospital Tg Mures
  • SC Medicali's SRL
  • Emergency Clinical County Hospital
  • Spitalul Judetean Timisoara
  • Policlinica Dr. Citu
  • Municipal medical Institution "City Hospital #1"
  • Municipal Institution "City Clinical Hospital #40"
  • State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1"
  • State Healthcare Institution "Kemerova Regional Clinical Hospital"
  • Federal State Institution "National Medical Surgery center named after NI Pirogov of Federal Agency of Health Care and Social Development"
  • 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
  • Russian University of Peoples Frienship (clinical base: City clinical hospital #53)
  • State Health Care Institution City Clinical Hospital named after SP Botkin
  • State healthcare Institution "Nizhegorodsky Regional Clinical Hospital named after NA Semashko"
  • State Healthcare Institution "Reoublic Hospital named after VA Baranov"
  • Municipal healthcare Institution "City Clinical Hospital #2"
  • State Healthcare Institution "Ryazan Regional Cardiological Dispensary"
  • State Educational Institution of High Professional Education Saratov State Medical University of Roszdrav
  • State Educational Institution of Higher Professional Education "Smolensk State Medical Academy of Federal Agency of Health Care and Social Development"
  • State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy for Postgraduate studies of Roszdrav"
  • St. Petersburg State Healthcare Institution "City Mariinsky Hospital"
  • State Institution "St. petersburg Clinical research Institute of Emergency Medical Care named after I.I. Dzhanelidze"
  • St. Petersburg State Healthcare Institution "City Outpatient Clinic #17"
  • State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy named after I.I. Mechnikov of Roszdrav"
  • State Institute St. Petersburg
  • State Educational Institution of Higher Professional Education "St. Petersburg State Medical Institute named after IP Pavlov of Roszdrav"
  • State Institution Scientific Research Institute of Cardiology of Tomsk Research Center of Siberian Branch of Russian Academy of Medical Sciences
  • SibMedCenter LLC
  • Municipal Healthcare Institution "City Clinical Hospital #2"
  • State Healthcare Institution of Yaroslavl region "Regional Clinical Hosptal"
  • SMOLKO s.r.o.
  • MEDIKOL s.r.o.
  • FN Trnava

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

HX575, EPO HEXAL

ERYPO

Outcomes

Primary Outcome Measures

Change in Hemoglobin Level
Mean absolute change in hemoglobin (baseline to end of study week 13)
Weekly Epoetin Dose
Mean weekly epoetin dose [IU/kg] in study weeks 11-13

Secondary Outcome Measures

Immunogenicity
Number of participants with antibody formation against Epoetin during treatment period (safety set)

Full Information

First Posted
June 17, 2008
Last Updated
July 13, 2017
Sponsor
Sandoz
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1. Study Identification

Unique Protocol Identification Number
NCT00701714
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
investigation of adverse events
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, controlled, double-blind, multicenter multinational safety study involving about 300 predialysis patients aged 18 years or above suffering from anemia. Symptomatic anemia will be corrected by s.c. application of EPO HEXAL or ERYPO® in order to achieve a hemoglobin target range of 10.0 -12.0 g/dL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Chronic Renal Insufficiency
Keywords
Treatment, associated, with CRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
337 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
HX575, EPO HEXAL
Arm Title
2
Arm Type
Active Comparator
Arm Description
ERYPO
Intervention Type
Drug
Intervention Name(s)
HX575 recombinant human erythropoietin alfa
Intervention Description
Solution for injection (s.c.)
Intervention Type
Drug
Intervention Name(s)
ERYPO
Intervention Description
Solution for injection (s.c.)
Primary Outcome Measure Information:
Title
Change in Hemoglobin Level
Description
Mean absolute change in hemoglobin (baseline to end of study week 13)
Time Frame
13 weeks
Title
Weekly Epoetin Dose
Description
Mean weekly epoetin dose [IU/kg] in study weeks 11-13
Time Frame
weeks 11-13
Secondary Outcome Measure Information:
Title
Immunogenicity
Description
Number of participants with antibody formation against Epoetin during treatment period (safety set)
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Known chronic renal insufficiency of at least 4 weeks duration; CKD stage at least 3 or higher Male and female patients, age: >=18 Patients who are naïve to ESA treatment or previously ESA treated after 3 months of ESA-free period (i.v. or s.c.) Patients with symptomatic anemia, defined as Hb level below 11.0 g/dL and not lower than or equal to 7.5 g/dL on at least 2 visits during the screening period Adequate iron status, serum ferritin >= 100 µg/L or transferrin saturation >= 20% Ability to follow study instructions and likely to complete all required visits and compliant with subcutaneous administration Written informed consent of the patient. Exclusion Criteria: Anemia of non-renal causes Therapy with immunosuppressants (other than corticosteroids for chronic treatment) within 3 months before screening and during the study for patients with renal allograft in place or other chronic conditions (e.g. lupus erythematosus, rheumatic arthritis) Patients previously treated with chronic dialysis within the last 6 months (exception: one session of acute dialysis) Patients with acute deterioration of renal function during the screening phase according to the investigator's judgment Patients receiving any RBC/whole blood transfusion during the screening period Primary hematological disorder (e.g. myeloma, myelodysplastic syndrome, sickle cell anemia, hematological malignancy, hemolytic anemia) Evidence of uncontrolled diabetes mellitus (HbA1c > 10 % at visit -2) Evidence of severe hepatic dysfunction (e.g. ALT and/or AST above 2x upper limit of normal range; or gamma-GT above 3x upper limit of normal range) Clinical evidence of current uncontrolled or symptomatic hyperparathyroidism, defined as parathyroid hormone > 500 ng/L at visit -2. Uncontrolled hypertension, defined as a systolic blood pressure of >= 160 mmHg and a diastolic blood pressure measurement >= 100 mmHg (average of two values with at least one day between measurements) Congestive heart failure and/or angina pectoris [New York Heart Association (NYHA) class III and IV] History of stroke or myocardial infarction during the last 6 months prior to visit -2 Ongoing treatment with phenprocoumon or other cumarin derivates Thrombocytopenia (platelet count <100.000/µL) or leucopenia (white blood cell count < 2.000/µL) Gastrointestinal bleeding within the last 6 months prior to visit -2 or hemolysis Evidence of acute or chronic infection by a C-reactive protein value of > 30 mg/L Suspicion or known PRCA (pure red cell aplasia) Previously diagnosed HIV or acute hepatitis infection History of epilepsy or epileptic seizures or treatment for epilepsy within the past 6 months prior to screening Planned major surgery (with expected high blood loss) during the next 3 months or major surgery within the previous 3 months (except laser photocoagulation, access surgery) Clinical evidence of active malignant diseases within the last 5 years (except non-melanoma skin cancer) Pregnancy, breastfeeding women or women not using a highly effective birth control method (e.g. implants, injectables, combined oral contraceptives, IUD, sexual abstinence, vasectomised partner) Known history of severe drug related allergies (e.g. anaphylactic shock) Known allergy to one of the ingredients of the test product or hypersensitivity to mammalian-derived products Known or suspicion of any non-compliance with respect to subcutaneous treatment Simultaneous participation in another clinical study or participation in a study in the month preceding visit-2 or previously randomized in this study Participation in another ESA study in the 3 months preceding visit -2 Any other condition which at the investigator's discretion may put the patient at risk or which may confound the study results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Vetter, Dr.
Organizational Affiliation
Hexal AG
Official's Role
Study Chair
Facility Information:
Facility Name
Diakonissen KH Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
LKH Steyr
City
Steyr
ZIP/Postal Code
4400
Country
Austria
Facility Name
Krankenanstalt der Stadt Wien
City
Wien
ZIP/Postal Code
1030
Country
Austria
Facility Name
AKH Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Sozialmedizinisches Zentrum Ost Donauspital
City
Wien
ZIP/Postal Code
1220
Country
Austria
Facility Name
MHAT Pazardijk
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Facility Name
MHAT Sveti Ivan Rilski
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
MHAT Stara Zagora
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
MHAT "Sv. Anna"
City
Varna
ZIP/Postal Code
9002
Country
Bulgaria
Facility Name
Ambulance vnitrního lékarstvi
City
Brno
ZIP/Postal Code
61500
Country
Czechia
Facility Name
Nemocnice Kladno
City
Kladno
ZIP/Postal Code
27259
Country
Czechia
Facility Name
Litomyslska nemocnice, a.s.
City
Litomyšl
ZIP/Postal Code
57014
Country
Czechia
Facility Name
Nemocnice s poliklinikou v Novem Jicine
City
Novi Jicin
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Dialcorp, s.r.o.
City
Praha 4 - Michle
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
IKEM
City
Praha 4
ZIP/Postal Code
14021
Country
Czechia
Facility Name
FN Motol
City
Praha 5
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Nemocnice Prostìjov
City
Prostìjov
ZIP/Postal Code
79604
Country
Czechia
Facility Name
Nemocnice Šternberk
City
Šternberk
ZIP/Postal Code
78501
Country
Czechia
Facility Name
Nefrologická a interní amb.
City
Žïár n. Sázavou
ZIP/Postal Code
591 01
Country
Czechia
Facility Name
CHU d'Amiens - Hopital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU de Rouen - Hopital de Bois Guillaume
City
Bois-Guillaume
ZIP/Postal Code
76230
Country
France
Facility Name
Gesundheitszentrum Alzey
City
Alzey
ZIP/Postal Code
55232
Country
Germany
Facility Name
Studienzentrum Hämatologie / Onkologie / Diabetes
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. med. Gert-Peter Dragoun, Dr. med Günther Hevendehl
City
Aschaffenburg
ZIP/Postal Code
63741
Country
Germany
Facility Name
Nephrologische Praxis Bad Münder
City
Bad Münder
ZIP/Postal Code
31848
Country
Germany
Facility Name
Praxis Dr. Scharla
City
Bad Reichenhall
ZIP/Postal Code
83435
Country
Germany
Facility Name
Nephrologisches Zentrum an Stadtkrankenhaus
City
Bad Wildungen
ZIP/Postal Code
34537
Country
Germany
Facility Name
Dialyse-Centrum
City
Bad Windsheim
ZIP/Postal Code
91438
Country
Germany
Facility Name
KfH Kuratorium f. Dialyse und Nierentransplantation e.V.
City
Bergisch Gladbach
ZIP/Postal Code
51465
Country
Germany
Facility Name
Schwerpunktpraxis für Diabetologie und Nephrologie
City
Bernkastel-Kues
ZIP/Postal Code
54470
Country
Germany
Facility Name
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
City
Bischofswerda
ZIP/Postal Code
01877
Country
Germany
Facility Name
Nephrologische Gemeinschaftspraxis Dr. Rensinghoff & Dr. Becker
City
Bochum-Wattenscheid
ZIP/Postal Code
44866
Country
Germany
Facility Name
Dialysepraxis drs. Riedasch/Schreiber
City
Coesfeld
ZIP/Postal Code
48653
Country
Germany
Facility Name
Praxis Dr. Kraatz
City
Demmin
ZIP/Postal Code
17109
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Steffen & Dr. Perino
City
Dinkelsbühl
ZIP/Postal Code
91550
Country
Germany
Facility Name
Diabetes- und Dialysezentrum Merker, Vogt
City
Dormagen
ZIP/Postal Code
41539
Country
Germany
Facility Name
Gemeinschaftspraxis Karlstraße
City
Düsseldorf
ZIP/Postal Code
40210
Country
Germany
Facility Name
Dialysepraxis Häger, Schanze, Brause
City
Düsseldorf
ZIP/Postal Code
40211
Country
Germany
Facility Name
KfH Kuratorium f. Dialyse und Nierentransplantation e.V.
City
Eberswalde
ZIP/Postal Code
16225
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel
City
Essen
ZIP/Postal Code
45127
Country
Germany
Facility Name
Praxis Dr. Zimmermann
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Praxis Dr. Lüdemann
City
Falkensee
ZIP/Postal Code
14612
Country
Germany
Facility Name
Dialysepraxis
City
Friedrichroda
ZIP/Postal Code
99894
Country
Germany
Facility Name
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
City
Fürstenzell
ZIP/Postal Code
94081
Country
Germany
Facility Name
Dialysepraxis Barmbek
City
Hamburg
ZIP/Postal Code
22297
Country
Germany
Facility Name
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
City
Haßfurt
ZIP/Postal Code
97437
Country
Germany
Facility Name
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
City
Heringen
ZIP/Postal Code
36266
Country
Germany
Facility Name
Dialysezentrum
City
Homberg/Efze
ZIP/Postal Code
34576
Country
Germany
Facility Name
Gemeinschaftspraxis und Dialyse
City
Hürth
ZIP/Postal Code
50354
Country
Germany
Facility Name
Dialyseplaxis DR. Rieck, DR. Göbel, DR. Wagner
City
Krefeld
ZIP/Postal Code
47798
Country
Germany
Facility Name
Leipziger Institut für Präventivmedizin
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Med Center Leipzig
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
Facility Name
GDG Gemeinnützige Dialyse Gesellschaft
City
Leverkusen
ZIP/Postal Code
51373
Country
Germany
Facility Name
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
City
Ludwigshafen
ZIP/Postal Code
67059
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Leistikow, Hafezi und Sandner
City
Mannheim
ZIP/Postal Code
68309
Country
Germany
Facility Name
Praxis Dr. Schütterle
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Praxis Dr. Vogel-Wagner
City
Mittweida
ZIP/Postal Code
09648
Country
Germany
Facility Name
Praxis Dr. Rose, Pohlmeier und Dr. Lammers
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Dialyse Nettetal
City
Nettetal
ZIP/Postal Code
41334
Country
Germany
Facility Name
KfH Kuratorium für dialyse und Nierentransplantation e.V.
City
Nördlingen
ZIP/Postal Code
86720
Country
Germany
Facility Name
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
City
Passau
ZIP/Postal Code
94032
Country
Germany
Facility Name
Praxis Dipl. med. Kosch
City
Pirna
ZIP/Postal Code
01796
Country
Germany
Facility Name
Dialysepraxis Dipl. med. Gierak & Dipl. med. Rettig
City
Quedlinburg
ZIP/Postal Code
06484
Country
Germany
Facility Name
Klinik für Nephrologie und Allgemeine Innere Medizin
City
Solingen
ZIP/Postal Code
42653
Country
Germany
Facility Name
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
City
Straubing
ZIP/Postal Code
94315
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Kirchner und Dr. Menge
City
Sömmerda
ZIP/Postal Code
99610
Country
Germany
Facility Name
Praxis Dr. med. Mauersberger
City
Villingen-Schwenningen
ZIP/Postal Code
78054
Country
Germany
Facility Name
Kamineni Hospitals Ltd.
City
Hyderabaad
ZIP/Postal Code
500068
Country
India
Facility Name
NIZAM Institute of Medical Sciences
City
Hyderabaad
ZIP/Postal Code
500082
Country
India
Facility Name
Bombay Hospital
City
Indore
ZIP/Postal Code
452010
Country
India
Facility Name
Monilek Hospital and Research Center
City
Jaipur
ZIP/Postal Code
302004
Country
India
Facility Name
Vinaya Hospital & Research Centre
City
Mangalore
ZIP/Postal Code
575003
Country
India
Facility Name
Pulse Diagnostix Cardiac and Medical Center
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Kerala Institute of Medical Sciences
City
Trivandrum
ZIP/Postal Code
695029
Country
India
Facility Name
SP ZOZ Miejski Szpital Zespolony
City
Czestochowa
ZIP/Postal Code
42200
Country
Poland
Facility Name
Specjalistyczna Przychodnia Lekarska Medikard
City
Plock
ZIP/Postal Code
09-402
Country
Poland
Facility Name
Szpital Wojewódzki w Poznaniu
City
Poznan
ZIP/Postal Code
60-479
Country
Poland
Facility Name
Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwor (Solumed SC)
City
Poznan
ZIP/Postal Code
60-539
Country
Poland
Facility Name
NZOZ NEFROLUX Sp. J. Lucjan Sobieraj, Wojciech Kaminski
City
Siemianowice Slaskie
ZIP/Postal Code
41100
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny nr. 1 im. Jozefa Gasinskiego
City
Tychy
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Szpital Praski p.w. Przemienienia Panskiego II Oddzia Chorob Wewnetrznych
City
Warszawa
ZIP/Postal Code
03401
Country
Poland
Facility Name
NZOZ Centrum Badan Klinicznych
City
Wroclaw
ZIP/Postal Code
50-349
Country
Poland
Facility Name
Centrul Medical de Diagnostic si Tratament Ambulator si Medicina Preventiva Bucuresti
City
Bucuresti
ZIP/Postal Code
011794
Country
Romania
Facility Name
Institutul National de DiabetNutritie si Boli Metabolice Paulescu
City
Bucuresti
ZIP/Postal Code
020475
Country
Romania
Facility Name
Institutul Clinic Fundeni
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Spitalul Universitar Bucuresti
City
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Facility Name
Spitalul Clinic Judetean Cluj
City
Cluj
ZIP/Postal Code
400 006
Country
Romania
Facility Name
County Hospital Deva
City
Deva
ZIP/Postal Code
330084
Country
Romania
Facility Name
Spitalul Clinic CI Parhon Iasi
City
Iasi
ZIP/Postal Code
700503
Country
Romania
Facility Name
Dr. Gavril Curteanu Clinical Hospital
City
Oradea
ZIP/Postal Code
410469
Country
Romania
Facility Name
County Hospital Tg Mures
City
Tg Mures
ZIP/Postal Code
540103
Country
Romania
Facility Name
SC Medicali's SRL
City
Timisoara
ZIP/Postal Code
300359
Country
Romania
Facility Name
Emergency Clinical County Hospital
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Spitalul Judetean Timisoara
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Policlinica Dr. Citu
City
Timisoara
ZIP/Postal Code
300766
Country
Romania
Facility Name
Municipal medical Institution "City Hospital #1"
City
Barnaul
ZIP/Postal Code
656099
Country
Russian Federation
Facility Name
Municipal Institution "City Clinical Hospital #40"
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1"
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
State Healthcare Institution "Kemerova Regional Clinical Hospital"
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Federal State Institution "National Medical Surgery center named after NI Pirogov of Federal Agency of Health Care and Social Development"
City
Moscow
ZIP/Postal Code
105203
Country
Russian Federation
Facility Name
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
City
Moscow
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
Russian University of Peoples Frienship (clinical base: City clinical hospital #53)
City
Moscow
ZIP/Postal Code
115432
Country
Russian Federation
Facility Name
State Health Care Institution City Clinical Hospital named after SP Botkin
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
State healthcare Institution "Nizhegorodsky Regional Clinical Hospital named after NA Semashko"
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
State Healthcare Institution "Reoublic Hospital named after VA Baranov"
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Municipal healthcare Institution "City Clinical Hospital #2"
City
Pyatigorsk
ZIP/Postal Code
357538
Country
Russian Federation
Facility Name
State Healthcare Institution "Ryazan Regional Cardiological Dispensary"
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
State Educational Institution of High Professional Education Saratov State Medical University of Roszdrav
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education "Smolensk State Medical Academy of Federal Agency of Health Care and Social Development"
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy for Postgraduate studies of Roszdrav"
City
St. Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution "City Mariinsky Hospital"
City
St. Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
State Institution "St. petersburg Clinical research Institute of Emergency Medical Care named after I.I. Dzhanelidze"
City
St. petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution "City Outpatient Clinic #17"
City
St. petersburg
ZIP/Postal Code
194358
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy named after I.I. Mechnikov of Roszdrav"
City
St. Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
State Institute St. Petersburg
City
St. Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education "St. Petersburg State Medical Institute named after IP Pavlov of Roszdrav"
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
State Institution Scientific Research Institute of Cardiology of Tomsk Research Center of Siberian Branch of Russian Academy of Medical Sciences
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation
Facility Name
SibMedCenter LLC
City
Tomsk
ZIP/Postal Code
634041
Country
Russian Federation
Facility Name
Municipal Healthcare Institution "City Clinical Hospital #2"
City
Yaroslavl
ZIP/Postal Code
150010
Country
Russian Federation
Facility Name
State Healthcare Institution of Yaroslavl region "Regional Clinical Hosptal"
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
SMOLKO s.r.o.
City
Kosice
ZIP/Postal Code
04001
Country
Slovakia
Facility Name
MEDIKOL s.r.o.
City
Košice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
FN Trnava
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia

12. IPD Sharing Statement

Learn more about this trial

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

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