Clinical trial NCT00701714: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anemia
Chronic Renal Insufficiency
Keywords: Treatment
associated
with CRI
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Hemoglobin Level
timeFrame: 13 weeks
measure: Weekly Epoetin Dose
timeFrame: weeks 11-13
Secondary outcomes:
measure: Immunogenicity
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Diakonissen KH Salzburg
city: Steyr
country: Austria
facility: LKH Steyr
city: Wien
country: Austria
facility: Krankenanstalt der Stadt Wien
city: Wien
country: Austria
facility: AKH Wien
city: Wien
country: Austria
facility: Sozialmedizinisches Zentrum Ost Donauspital
city: Pazardzhik
country: Bulgaria
facility: MHAT Pazardijk
city: Sofia
country: Bulgaria
facility: MHAT Sveti Ivan Rilski
city: Stara Zagora
country: Bulgaria
facility: MHAT Stara Zagora
city: Varna
country: Bulgaria
facility: MHAT "Sv. Anna"
city: Brno
country: Czechia
facility: Ambulance vnitrního lékarstvi
city: Kladno
country: Czechia
facility: Nemocnice Kladno
city: Litomyšl
country: Czechia
facility: Litomyslska nemocnice, a.s.
city: Novi Jicin
country: Czechia
facility: Nemocnice s poliklinikou v Novem Jicine
city: Praha 4 - Michle
country: Czechia
facility: Dialcorp, s.r.o.
city: Praha 4
country: Czechia
facility: IKEM
city: Praha 5
country: Czechia
facility: FN Motol
city: Prostìjov
country: Czechia
facility: Nemocnice Prostìjov
city: Šternberk
country: Czechia
facility: Nemocnice Šternberk
city: Žïár n. Sázavou
country: Czechia
facility: Nefrologická a interní amb.
city: Amiens
country: France
facility: CHU d'Amiens - Hopital Sud
city: Bois-Guillaume
country: France
facility: CHU de Rouen - Hopital de Bois Guillaume
city: Alzey
country: Germany
facility: Gesundheitszentrum Alzey
city: Aschaffenburg
country: Germany
facility: Studienzentrum Hämatologie / Onkologie / Diabetes
city: Aschaffenburg
country: Germany
facility: Gemeinschaftspraxis Dr. med. Gert-Peter Dragoun, Dr. med Günther Hevendehl
city: Bad Münder
country: Germany
facility: Nephrologische Praxis Bad Münder
city: Bad Reichenhall
country: Germany
facility: Praxis Dr. Scharla
city: Bad Wildungen
country: Germany
facility: Nephrologisches Zentrum an Stadtkrankenhaus
city: Bad Windsheim
country: Germany
facility: Dialyse-Centrum
city: Bergisch Gladbach
country: Germany
facility: KfH Kuratorium f. Dialyse und Nierentransplantation e.V.
city: Bernkastel-Kues
country: Germany
facility: Schwerpunktpraxis für Diabetologie und Nephrologie
city: Bischofswerda
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
city: Bochum-Wattenscheid
country: Germany
facility: Nephrologische Gemeinschaftspraxis Dr. Rensinghoff & Dr. Becker
city: Coesfeld
country: Germany
facility: Dialysepraxis drs. Riedasch/Schreiber
city: Demmin
country: Germany
facility: Praxis Dr. Kraatz
city: Dinkelsbühl
country: Germany
facility: Gemeinschaftspraxis Dr. Steffen & Dr. Perino
city: Dormagen
country: Germany
facility: Diabetes- und Dialysezentrum Merker, Vogt
city: Düsseldorf
country: Germany
facility: Gemeinschaftspraxis Karlstraße
city: Düsseldorf
country: Germany
facility: Dialysepraxis Häger, Schanze, Brause
city: Eberswalde
country: Germany
facility: KfH Kuratorium f. Dialyse und Nierentransplantation e.V.
city: Essen
country: Germany
facility: Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel
city: Essen
country: Germany
facility: Praxis Dr. Zimmermann
city: Falkensee
country: Germany
facility: Praxis Dr. Lüdemann
city: Friedrichroda
country: Germany
facility: Dialysepraxis
city: Fürstenzell
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
city: Hamburg
country: Germany
facility: Dialysepraxis Barmbek
city: Haßfurt
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
city: Heringen
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
city: Homberg/Efze
country: Germany
facility: Dialysezentrum
city: Hürth
country: Germany
facility: Gemeinschaftspraxis und Dialyse
city: Krefeld
country: Germany
facility: Dialyseplaxis DR. Rieck, DR. Göbel, DR. Wagner
city: Leipzig
country: Germany
facility: Leipziger Institut für Präventivmedizin
city: Leipzig
country: Germany
facility: Med Center Leipzig
city: Leverkusen
country: Germany
facility: GDG Gemeinnützige Dialyse Gesellschaft
city: Ludwigshafen
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
city: Mannheim
country: Germany
facility: Gemeinschaftspraxis Dres. Leistikow, Hafezi und Sandner
city: Marburg
country: Germany
facility: Praxis Dr. Schütterle
city: Mittweida
country: Germany
facility: Praxis Dr. Vogel-Wagner
city: Münster
country: Germany
facility: Praxis Dr. Rose, Pohlmeier und Dr. Lammers
city: Nettetal
country: Germany
facility: Dialyse Nettetal
city: Nördlingen
country: Germany
facility: KfH Kuratorium für dialyse und Nierentransplantation e.V.
city: Passau
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
city: Pirna
country: Germany
facility: Praxis Dipl. med. Kosch
city: Quedlinburg
country: Germany
facility: Dialysepraxis Dipl. med. Gierak & Dipl. med. Rettig
city: Solingen
country: Germany
facility: Klinik für Nephrologie und Allgemeine Innere Medizin
city: Straubing
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
city: Sömmerda
country: Germany
facility: Gemeinschaftspraxis Dr. Kirchner und Dr. Menge
city: Villingen-Schwenningen
country: Germany
facility: Praxis Dr. med. Mauersberger
city: Hyderabaad
country: India
facility: Kamineni Hospitals Ltd.
city: Hyderabaad
country: India
facility: NIZAM Institute of Medical Sciences
city: Indore
country: India
facility: Bombay Hospital
city: Jaipur
country: India
facility: Monilek Hospital and Research Center
city: Mangalore
country: India
facility: Vinaya Hospital & Research Centre
city: Pune
country: India
facility: Pulse Diagnostix Cardiac and Medical Center
city: Trivandrum
country: India
facility: Kerala Institute of Medical Sciences
city: Czestochowa
country: Poland
facility: SP ZOZ Miejski Szpital Zespolony
city: Plock
country: Poland
facility: Specjalistyczna Przychodnia Lekarska Medikard
city: Poznan
country: Poland
facility: Szpital Wojewódzki w Poznaniu
city: Poznan
country: Poland
facility: Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwor (Solumed SC)
city: Siemianowice Slaskie
country: Poland
facility: NZOZ NEFROLUX Sp. J. Lucjan Sobieraj, Wojciech Kaminski
city: Tychy
country: Poland
facility: Wojewodzki Szpital Specjalistyczny nr. 1 im. Jozefa Gasinskiego
city: Warszawa
country: Poland
facility: Szpital Praski p.w. Przemienienia Panskiego II Oddzia Chorob Wewnetrznych
city: Wroclaw
country: Poland
facility: NZOZ Centrum Badan Klinicznych
city: Bucuresti
country: Romania
facility: Centrul Medical de Diagnostic si Tratament Ambulator si Medicina Preventiva Bucuresti
city: Bucuresti
country: Romania
facility: Institutul National de DiabetNutritie si Boli Metabolice Paulescu
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Bucuresti
country: Romania
facility: Spitalul Universitar Bucuresti
city: Cluj
country: Romania
facility: Spitalul Clinic Judetean Cluj
city: Deva
country: Romania
facility: County Hospital Deva
city: Iasi
country: Romania
facility: Spitalul Clinic CI Parhon Iasi
city: Oradea
country: Romania
facility: Dr. Gavril Curteanu Clinical Hospital
city: Tg Mures
country: Romania
facility: County Hospital Tg Mures
city: Timisoara
country: Romania
facility: SC Medicali's SRL
city: Timisoara
country: Romania
facility: Emergency Clinical County Hospital
city: Timisoara
country: Romania
facility: Spitalul Judetean Timisoara
city: Timisoara
country: Romania
facility: Policlinica Dr. Citu
city: Barnaul
country: Russian Federation
facility: Municipal medical Institution "City Hospital #1"
city: Ekaterinburg
country: Russian Federation
facility: Municipal Institution "City Clinical Hospital #40"
city: Ekaterinburg
country: Russian Federation
facility: State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1"
city: Kemerovo
country: Russian Federation
facility: State Healthcare Institution "Kemerova Regional Clinical Hospital"
city: Moscow
country: Russian Federation
facility: Federal State Institution "National Medical Surgery center named after NI Pirogov of Federal Agency of Health Care and Social Development"
city: Moscow
country: Russian Federation
facility: 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
country: Russian Federation
facility: Russian University of Peoples Frienship (clinical base: City clinical hospital #53)
city: Moscow
country: Russian Federation
facility: State Health Care Institution City Clinical Hospital named after SP Botkin
city: Nizhniy Novgorod
country: Russian Federation
facility: State healthcare Institution "Nizhegorodsky Regional Clinical Hospital named after NA Semashko"
city: Petrozavodsk
country: Russian Federation
facility: State Healthcare Institution "Reoublic Hospital named after VA Baranov"
city: Pyatigorsk
country: Russian Federation
facility: Municipal healthcare Institution "City Clinical Hospital #2"
city: Ryazan
country: Russian Federation
facility: State Healthcare Institution "Ryazan Regional Cardiological Dispensary"
city: Saratov
country: Russian Federation
facility: State Educational Institution of High Professional Education Saratov State Medical University of Roszdrav
city: Smolensk
country: Russian Federation
facility: State Educational Institution of Higher Professional Education "Smolensk State Medical Academy of Federal Agency of Health Care and Social Development"
city: St. Petersburg
country: Russian Federation
facility: State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy for Postgraduate studies of Roszdrav"
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution "City Mariinsky Hospital"
city: St. petersburg
country: Russian Federation
facility: State Institution "St. petersburg Clinical research Institute of Emergency Medical Care named after I.I. Dzhanelidze"
city: St. petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution "City Outpatient Clinic #17"
city: St. Petersburg
country: Russian Federation
facility: State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy named after I.I. Mechnikov of Roszdrav"
city: St. Petersburg
country: Russian Federation
facility: State Institute St. Petersburg
city: St. Petersburg
country: Russian Federation
facility: State Educational Institution of Higher Professional Education "St. Petersburg State Medical Institute named after IP Pavlov of Roszdrav"
city: Tomsk
country: Russian Federation
facility: State Institution Scientific Research Institute of Cardiology of Tomsk Research Center of Siberian Branch of Russian Academy of Medical Sciences
city: Tomsk
country: Russian Federation
facility: SibMedCenter LLC
city: Yaroslavl
country: Russian Federation
facility: Municipal Healthcare Institution "City Clinical Hospital #2"
city: Yaroslavl
country: Russian Federation
facility: State Healthcare Institution of Yaroslavl region "Regional Clinical Hosptal"
city: Kosice
country: Slovakia
facility: SMOLKO s.r.o.
city: Košice
country: Slovakia
facility: MEDIKOL s.r.o.
city: Trnava
country: Slovakia
facility: FN Trnava
Study officials:
affiliation: Hexal AG
name: Andrea Vetter, Dr.
role: STUDY_CHAIR
References: