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

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

Sponsors

Lead sponsor: Sandoz

Source Sandoz
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.

Overall Status Terminated
Start Date September 2007
Completion Date January 2010
Primary Completion Date July 2009
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Hemoglobin Level 13 weeks
Weekly Epoetin Dose weeks 11-13
Secondary Outcome
Measure Time Frame
Immunogenicity 13 weeks
Enrollment 337
Condition
Intervention

Intervention type: Drug

Intervention name: HX575 recombinant human erythropoietin alfa

Description: Solution for injection (s.c.)

Arm group label: 1

Intervention type: Drug

Intervention name: ERYPO

Description: Solution for injection (s.c.)

Arm group label: 2

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Andrea Vetter, Dr. Study Chair Hexal AG
Location
facility
Diakonissen KH Salzburg | Salzburg, 5020, Austria
LKH Steyr | Steyr, 4400, Austria
Krankenanstalt der Stadt Wien | Wien, 1030, Austria
AKH Wien | Wien, 1090, Austria
Sozialmedizinisches Zentrum Ost Donauspital | Wien, 1220, Austria
MHAT Pazardijk | Pazardzhik, 4400, Bulgaria
MHAT Sveti Ivan Rilski | Sofia, 1431, Bulgaria
MHAT Stara Zagora | Stara Zagora, 6003, Bulgaria
MHAT "Sv. Anna" | Varna, 9002, Bulgaria
Ambulance vnitrního lékarstvi | Brno, 61500, Czechia
Nemocnice Kladno | Kladno, 27259, Czechia
Litomyslska nemocnice, a.s. | Litomyšl, 57014, Czechia
Nemocnice s poliklinikou v Novem Jicine | Novi Jicin, 741 01, Czechia
Dialcorp, s.r.o. | Praha 4 - Michle, 140 00, Czechia
IKEM | Praha 4, 14021, Czechia
FN Motol | Praha 5, 15006, Czechia
Nemocnice Prostìjov | Prostìjov, 79604, Czechia
Nemocnice Šternberk | Šternberk, 78501, Czechia
Nefrologická a interní amb. | Žïár n. Sázavou, 591 01, Czechia
CHU d'Amiens - Hopital Sud | Amiens, 80054, France
CHU de Rouen - Hopital de Bois Guillaume | Bois-Guillaume, 76230, France
Gesundheitszentrum Alzey | Alzey, 55232, Germany
Studienzentrum Hämatologie / Onkologie / Diabetes | Aschaffenburg, 63739, Germany
Gemeinschaftspraxis Dr. med. Gert-Peter Dragoun, Dr. med Günther Hevendehl | Aschaffenburg, 63741, Germany
Nephrologische Praxis Bad Münder | Bad Münder, 31848, Germany
Praxis Dr. Scharla | Bad Reichenhall, 83435, Germany
Nephrologisches Zentrum an Stadtkrankenhaus | Bad Wildungen, 34537, Germany
Dialyse-Centrum | Bad Windsheim, 91438, Germany
KfH Kuratorium f. Dialyse und Nierentransplantation e.V. | Bergisch Gladbach, 51465, Germany
Schwerpunktpraxis für Diabetologie und Nephrologie | Bernkastel-Kues, 54470, Germany
KfH Kuratorium für Dialyse und Nierentransplantation e.V. | Bischofswerda, 01877, Germany
Nephrologische Gemeinschaftspraxis Dr. Rensinghoff & Dr. Becker | Bochum-Wattenscheid, 44866, Germany
Dialysepraxis drs. Riedasch/Schreiber | Coesfeld, 48653, Germany
Praxis Dr. Kraatz | Demmin, 17109, Germany
Gemeinschaftspraxis Dr. Steffen & Dr. Perino | Dinkelsbühl, 91550, Germany
Diabetes- und Dialysezentrum Merker, Vogt | Dormagen, 41539, Germany
Gemeinschaftspraxis Karlstraße | Düsseldorf, 40210, Germany
Dialysepraxis Häger, Schanze, Brause | Düsseldorf, 40211, Germany
KfH Kuratorium f. Dialyse und Nierentransplantation e.V. | Eberswalde, 16225, Germany
Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel | Essen, 45127, Germany
Praxis Dr. Zimmermann | Essen, 45136, Germany
Praxis Dr. Lüdemann | Falkensee, 14612, Germany
Dialysepraxis | Friedrichroda, 99894, Germany
KfH Kuratorium für Dialyse und Nierentransplantation e.V. | Fürstenzell, 94081, Germany
Dialysepraxis Barmbek | Hamburg, 22297, Germany
KfH Kuratorium für Dialyse und Nierentransplantation e.V. | Haßfurt, 97437, Germany
KfH Kuratorium für Dialyse und Nierentransplantation e.V. | Heringen, 36266, Germany
Dialysezentrum | Homberg/Efze, 34576, Germany
Gemeinschaftspraxis und Dialyse | Hürth, 50354, Germany
Dialyseplaxis DR. Rieck, DR. Göbel, DR. Wagner | Krefeld, 47798, Germany
Leipziger Institut für Präventivmedizin | Leipzig, 04103, Germany
Med Center Leipzig | Leipzig, 04107, Germany
GDG Gemeinnützige Dialyse Gesellschaft | Leverkusen, 51373, Germany
KfH Kuratorium für Dialyse und Nierentransplantation e.V. | Ludwigshafen, 67059, Germany
Gemeinschaftspraxis Dres. Leistikow, Hafezi und Sandner | Mannheim, 68309, Germany
Praxis Dr. Schütterle | Marburg, 35043, Germany
Praxis Dr. Vogel-Wagner | Mittweida, 09648, Germany
Praxis Dr. Rose, Pohlmeier und Dr. Lammers | Münster, 48145, Germany
Dialyse Nettetal | Nettetal, 41334, Germany
KfH Kuratorium für dialyse und Nierentransplantation e.V. | Nördlingen, 86720, Germany
KfH Kuratorium für Dialyse und Nierentransplantation e.V. | Passau, 94032, Germany
Praxis Dipl. med. Kosch | Pirna, 01796, Germany
Dialysepraxis Dipl. med. Gierak & Dipl. med. Rettig | Quedlinburg, 06484, Germany
Klinik für Nephrologie und Allgemeine Innere Medizin | Solingen, 42653, Germany
KfH Kuratorium für Dialyse und Nierentransplantation e.V. | Straubing, 94315, Germany
Gemeinschaftspraxis Dr. Kirchner und Dr. Menge | Sömmerda, 99610, Germany
Praxis Dr. med. Mauersberger | Villingen-Schwenningen, 78054, Germany
Kamineni Hospitals Ltd. | Hyderabaad, 500068, India
NIZAM Institute of Medical Sciences | Hyderabaad, 500082, India
Bombay Hospital | Indore, 452010, India
Monilek Hospital and Research Center | Jaipur, 302004, India
Vinaya Hospital & Research Centre | Mangalore, 575003, India
Pulse Diagnostix Cardiac and Medical Center | Pune, 411001, India
Kerala Institute of Medical Sciences | Trivandrum, 695029, India
SP ZOZ Miejski Szpital Zespolony | Czestochowa, 42200, Poland
Specjalistyczna Przychodnia Lekarska Medikard | Plock, 09-402, Poland
Szpital Wojewódzki w Poznaniu | Poznan, 60-479, Poland
Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwor (Solumed SC) | Poznan, 60-539, Poland
NZOZ NEFROLUX Sp. J. Lucjan Sobieraj, Wojciech Kaminski | Siemianowice Slaskie, 41100, Poland
Wojewodzki Szpital Specjalistyczny nr. 1 im. Jozefa Gasinskiego | Tychy, 43-100, Poland
Szpital Praski p.w. Przemienienia Panskiego II Oddzia Chorob Wewnetrznych | Warszawa, 03401, Poland
NZOZ Centrum Badan Klinicznych | Wroclaw, 50-349, Poland
Centrul Medical de Diagnostic si Tratament Ambulator si Medicina Preventiva Bucuresti | Bucuresti, 011794, Romania
Institutul National de DiabetNutritie si Boli Metabolice Paulescu | Bucuresti, 020475, Romania
Institutul Clinic Fundeni | Bucuresti, 022328, Romania
Spitalul Universitar Bucuresti | Bucuresti, 050098, Romania
Spitalul Clinic Judetean Cluj | Cluj, 400 006, Romania
County Hospital Deva | Deva, 330084, Romania
Spitalul Clinic CI Parhon Iasi | Iasi, 700503, Romania
Dr. Gavril Curteanu Clinical Hospital | Oradea, 410469, Romania
County Hospital Tg Mures | Tg Mures, 540103, Romania
SC Medicali's SRL | Timisoara, 300359, Romania
Emergency Clinical County Hospital | Timisoara, 300736, Romania
Spitalul Judetean Timisoara | Timisoara, 300736, Romania
Policlinica Dr. Citu | Timisoara, 300766, Romania
Municipal medical Institution "City Hospital #1" | Barnaul, 656099, Russian Federation
Municipal Institution "City Clinical Hospital #40" | Ekaterinburg, 620102, Russian Federation
State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1" | Ekaterinburg, 620102, Russian Federation
State Healthcare Institution "Kemerova Regional Clinical Hospital" | Kemerovo, 650066, Russian Federation
Federal State Institution "National Medical Surgery center named after NI Pirogov of Federal Agency of Health Care and Social Development" | Moscow, 105203, Russian Federation
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, 109240, Russian Federation
Russian University of Peoples Frienship (clinical base: City clinical hospital #53) | Moscow, 115432, Russian Federation
State Health Care Institution City Clinical Hospital named after SP Botkin | Moscow, 125284, Russian Federation
State healthcare Institution "Nizhegorodsky Regional Clinical Hospital named after NA Semashko" | Nizhniy Novgorod, 603126, Russian Federation
State Healthcare Institution "Reoublic Hospital named after VA Baranov" | Petrozavodsk, 185019, Russian Federation
Municipal healthcare Institution "City Clinical Hospital #2" | Pyatigorsk, 357538, Russian Federation
State Healthcare Institution "Ryazan Regional Cardiological Dispensary" | Ryazan, 390026, Russian Federation
State Educational Institution of High Professional Education Saratov State Medical University of Roszdrav | Saratov, 410053, Russian Federation
State Educational Institution of Higher Professional Education "Smolensk State Medical Academy of Federal Agency of Health Care and Social Development" | Smolensk, 214018, Russian Federation
State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy for Postgraduate studies of Roszdrav" | St. Petersburg, 191015, Russian Federation
St. Petersburg State Healthcare Institution "City Mariinsky Hospital" | St. Petersburg, 191104, Russian Federation
State Institution "St. petersburg Clinical research Institute of Emergency Medical Care named after I.I. Dzhanelidze" | St. petersburg, 192242, Russian Federation
St. Petersburg State Healthcare Institution "City Outpatient Clinic #17" | St. petersburg, 194358, Russian Federation
State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy named after I.I. Mechnikov of Roszdrav" | St. Petersburg, 195067, Russian Federation
State Institute St. Petersburg | St. Petersburg, 195067, Russian Federation
State Educational Institution of Higher Professional Education "St. Petersburg State Medical Institute named after IP Pavlov of Roszdrav" | St. Petersburg, 197022, Russian Federation
State Institution Scientific Research Institute of Cardiology of Tomsk Research Center of Siberian Branch of Russian Academy of Medical Sciences | Tomsk, 634012, Russian Federation
SibMedCenter LLC | Tomsk, 634041, Russian Federation
Municipal Healthcare Institution "City Clinical Hospital #2" | Yaroslavl, 150010, Russian Federation
State Healthcare Institution of Yaroslavl region "Regional Clinical Hosptal" | Yaroslavl, 150062, Russian Federation
SMOLKO s.r.o. | Kosice, 04001, Slovakia
MEDIKOL s.r.o. | Košice, 040 01, Slovakia
FN Trnava | Trnava, 917 75, Slovakia
Location Countries

Austria

Bulgaria

Czechia

France

Germany

India

Poland

Romania

Russian Federation

Slovakia

Verification Date

July 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: 1

Arm group type: Experimental

Description: HX575, EPO HEXAL

Arm group label: 2

Arm group type: Active Comparator

Description: ERYPO

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov