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
- Conditions
- AnemiaChronic Renal Insufficiency
- Interventions
- Registration Number
- NCT00701714
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 337
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 HX575 recombinant human erythropoietin alfa HX575, EPO HEXAL 2 ERYPO ERYPO
- Primary Outcome Measures
Name Time Method Change in Hemoglobin Level 13 weeks Mean absolute change in hemoglobin (baseline to end of study week 13)
Weekly Epoetin Dose weeks 11-13 Mean weekly epoetin dose \[IU/kg\] in study weeks 11-13
- Secondary Outcome Measures
Name Time Method Immunogenicity 13 weeks Number of participants with antibody formation against Epoetin during treatment period (safety set)
Trial Locations
- Locations (116)
Diakonissen KH Salzburg
🇦🇹Salzburg, Austria
LKH Steyr
🇦🇹Steyr, Austria
Krankenanstalt der Stadt Wien
🇦🇹Wien, Austria
Kamineni Hospitals Ltd.
🇮🇳Hyderabaad, India
MHAT Pazardijk
🇧🇬Pazardzhik, Bulgaria
MHAT Stara Zagora
🇧🇬Stara Zagora, Bulgaria
Spitalul Clinic Judetean Cluj
🇷🇴Cluj, Romania
County Hospital Tg Mures
🇷🇴Tg Mures, Romania
MHAT Sveti Ivan Rilski
🇧🇬Sofia, Bulgaria
Bombay Hospital
🇮🇳Indore, India
State Healthcare Institution "Kemerova Regional Clinical Hospital"
🇷🇺Kemerovo, Russian Federation
Russian University of Peoples Frienship (clinical base: City clinical hospital #53)
🇷🇺Moscow, Russian Federation
Monilek Hospital and Research Center
🇮🇳Jaipur, India
NZOZ NEFROLUX Sp. J. Lucjan Sobieraj, Wojciech Kaminski
🇵🇱Siemianowice Slaskie, Poland
Spitalul Universitar Bucuresti
🇷🇴Bucuresti, Romania
County Hospital Deva
🇷🇴Deva, Romania
SC Medicali's SRL
🇷🇴Timisoara, Romania
Szpital Wojewódzki w Poznaniu
🇵🇱Poznan, Poland
Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwor (Solumed SC)
🇵🇱Poznan, Poland
Wojewodzki Szpital Specjalistyczny nr. 1 im. Jozefa Gasinskiego
🇵🇱Tychy, Poland
Centrul Medical de Diagnostic si Tratament Ambulator si Medicina Preventiva Bucuresti
🇷🇴Bucuresti, Romania
Szpital Praski p.w. Przemienienia Panskiego II Oddzia Chorob Wewnetrznych
🇵🇱Warszawa, Poland
NZOZ Centrum Badan Klinicznych
🇵🇱Wroclaw, Poland
Institutul National de DiabetNutritie si Boli Metabolice Paulescu
🇷🇴Bucuresti, Romania
Institutul Clinic Fundeni
🇷🇴Bucuresti, Romania
Spitalul Judetean Timisoara
🇷🇴Timisoara, Romania
Policlinica Dr. Citu
🇷🇴Timisoara, Romania
State Healthcare Institution "Reoublic Hospital named after VA Baranov"
🇷🇺Petrozavodsk, Russian Federation
Municipal Institution "City Clinical Hospital #40"
🇷🇺Ekaterinburg, Russian Federation
Nemocnice Kladno
🇨🇿Kladno, Czechia
Gesundheitszentrum Alzey
🇩🇪Alzey, Germany
Nephrologisches Zentrum an Stadtkrankenhaus
🇩🇪Bad Wildungen, Germany
Praxis Dr. Scharla
🇩🇪Bad Reichenhall, Germany
Nemocnice s poliklinikou v Novem Jicine
🇨🇿Novi Jicin, Czechia
Dialysepraxis drs. Riedasch/Schreiber
🇩🇪Coesfeld, Germany
Gemeinschaftspraxis Karlstraße
🇩🇪Düsseldorf, Germany
FN Motol
🇨🇿Praha 5, Czechia
Gemeinschaftspraxis Dr. med. Gert-Peter Dragoun, Dr. med Günther Hevendehl
🇩🇪Aschaffenburg, Germany
Dialyseplaxis DR. Rieck, DR. Göbel, DR. Wagner
🇩🇪Krefeld, Germany
KfH Kuratorium für dialyse und Nierentransplantation e.V.
🇩🇪Nördlingen, Germany
Nephrologische Gemeinschaftspraxis Dr. Rensinghoff & Dr. Becker
🇩🇪Bochum-Wattenscheid, Germany
Dialcorp, s.r.o.
🇨🇿Praha 4 - Michle, Czechia
Nefrologická a interní amb.
🇨🇿Žïár n. Sázavou, Czechia
Studienzentrum Hämatologie / Onkologie / Diabetes
🇩🇪Aschaffenburg, Germany
Gemeinschaftspraxis und Dialyse
🇩🇪Hürth, Germany
Dialyse-Centrum
🇩🇪Bad Windsheim, Germany
KfH Kuratorium f. Dialyse und Nierentransplantation e.V.
🇩🇪Eberswalde, Germany
Gemeinschaftspraxis Dr. Steffen & Dr. Perino
🇩🇪Dinkelsbühl, Germany
Praxis Dr. Schütterle
🇩🇪Marburg, Germany
Praxis Dr. Rose, Pohlmeier und Dr. Lammers
🇩🇪Münster, Germany
Dialyse Nettetal
🇩🇪Nettetal, Germany
Nephrologische Praxis Bad Münder
🇩🇪Bad Münder, Germany
Nemocnice Šternberk
🇨🇿Šternberk, Czechia
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
🇩🇪Straubing, Germany
CHU d'Amiens - Hopital Sud
🇫🇷Amiens, France
GDG Gemeinnützige Dialyse Gesellschaft
🇩🇪Leverkusen, Germany
MHAT "Sv. Anna"
🇧🇬Varna, Bulgaria
Litomyslska nemocnice, a.s.
🇨🇿Litomyšl, Czechia
Schwerpunktpraxis für Diabetologie und Nephrologie
🇩🇪Bernkastel-Kues, Germany
Praxis Dr. Kraatz
🇩🇪Demmin, Germany
Nemocnice Prostìjov
🇨🇿Prostìjov, Czechia
Diabetes- und Dialysezentrum Merker, Vogt
🇩🇪Dormagen, Germany
Dialysepraxis
🇩🇪Friedrichroda, Germany
Gemeinschaftspraxis Dres. Leistikow, Hafezi und Sandner
🇩🇪Mannheim, Germany
IKEM
🇨🇿Praha 4, Czechia
Specjalistyczna Przychodnia Lekarska Medikard
🇵🇱Plock, Poland
Emergency Clinical County Hospital
🇷🇴Timisoara, Romania
NIZAM Institute of Medical Sciences
🇮🇳Hyderabaad, India
Dialysepraxis Häger, Schanze, Brause
🇩🇪Düsseldorf, Germany
Praxis Dr. med. Mauersberger
🇩🇪Villingen-Schwenningen, Germany
Dialysezentrum
🇩🇪Homberg/Efze, Germany
Praxis Dr. Zimmermann
🇩🇪Essen, Germany
Med Center Leipzig
🇩🇪Leipzig, Germany
Praxis Dr. Vogel-Wagner
🇩🇪Mittweida, Germany
Vinaya Hospital & Research Centre
🇮🇳Mangalore, India
Klinik für Nephrologie und Allgemeine Innere Medizin
🇩🇪Solingen, Germany
Pulse Diagnostix Cardiac and Medical Center
🇮🇳Pune, India
SP ZOZ Miejski Szpital Zespolony
🇵🇱Czestochowa, Poland
State Health Care Institution City Clinical Hospital named after SP Botkin
🇷🇺Moscow, Russian Federation
Municipal medical Institution "City Hospital #1"
🇷🇺Barnaul, 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, Russian Federation
Municipal Healthcare Institution "City Clinical Hospital #2"
🇷🇺Yaroslavl, Russian Federation
State Educational Institution of Higher Professional Education "Smolensk State Medical Academy of Federal Agency of Health Care and Social Development"
🇷🇺Smolensk, Russian Federation
Praxis Dr. Lüdemann
🇩🇪Falkensee, Germany
Leipziger Institut für Präventivmedizin
🇩🇪Leipzig, Germany
Dialysepraxis Barmbek
🇩🇪Hamburg, Germany
State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy named after I.I. Mechnikov of Roszdrav"
🇷🇺St. Petersburg, Russian Federation
State Institute St. Petersburg
🇷🇺St. Petersburg, Russian Federation
SibMedCenter LLC
🇷🇺Tomsk, Russian Federation
State Educational Institution of Higher Professional Education "St. Petersburg State Medical Institute named after IP Pavlov of Roszdrav"
🇷🇺St. Petersburg, Russian Federation
State Healthcare Institution of Yaroslavl region "Regional Clinical Hosptal"
🇷🇺Yaroslavl, Russian Federation
AKH Wien
🇦🇹Wien, Austria
Sozialmedizinisches Zentrum Ost Donauspital
🇦🇹Wien, Austria
Ambulance vnitrního lékarstvi
🇨🇿Brno, Czechia
CHU de Rouen - Hopital de Bois Guillaume
🇫🇷Bois-Guillaume, France
Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel
🇩🇪Essen, Germany
Praxis Dipl. med. Kosch
🇩🇪Pirna, Germany
Dialysepraxis Dipl. med. Gierak & Dipl. med. Rettig
🇩🇪Quedlinburg, Germany
Gemeinschaftspraxis Dr. Kirchner und Dr. Menge
🇩🇪Sömmerda, Germany
Kerala Institute of Medical Sciences
🇮🇳Trivandrum, India
Spitalul Clinic CI Parhon Iasi
🇷🇴Iasi, Romania
Dr. Gavril Curteanu Clinical Hospital
🇷🇴Oradea, Romania
State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1"
🇷🇺Ekaterinburg, Russian Federation
Federal State Institution "National Medical Surgery center named after NI Pirogov of Federal Agency of Health Care and Social Development"
🇷🇺Moscow, Russian Federation
State healthcare Institution "Nizhegorodsky Regional Clinical Hospital named after NA Semashko"
🇷🇺Nizhniy Novgorod, Russian Federation
Municipal healthcare Institution "City Clinical Hospital #2"
🇷🇺Pyatigorsk, Russian Federation
State Educational Institution of High Professional Education Saratov State Medical University of Roszdrav
🇷🇺Saratov, Russian Federation
State Healthcare Institution "Ryazan Regional Cardiological Dispensary"
🇷🇺Ryazan, Russian Federation
State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy for Postgraduate studies of Roszdrav"
🇷🇺St. Petersburg, Russian Federation
St. Petersburg State Healthcare Institution "City Mariinsky Hospital"
🇷🇺St. Petersburg, Russian Federation
State Institution "St. petersburg Clinical research Institute of Emergency Medical Care named after I.I. Dzhanelidze"
🇷🇺St. petersburg, Russian Federation
St. Petersburg State Healthcare Institution "City Outpatient Clinic #17"
🇷🇺St. petersburg, Russian Federation
State Institution Scientific Research Institute of Cardiology of Tomsk Research Center of Siberian Branch of Russian Academy of Medical Sciences
🇷🇺Tomsk, Russian Federation
SMOLKO s.r.o.
🇸🇰Kosice, Slovakia
MEDIKOL s.r.o.
🇸🇰Košice, Slovakia
FN Trnava
🇸🇰Trnava, Slovakia