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

NCT ID: NCT00701714

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 337 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-01-31

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.

Conditions

Anemia; Chronic Renal Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

HX575, EPO HEXAL

Group Type: EXPERIMENTAL

HX575 recombinant human erythropoietin alfa

Intervention Type: DRUG

Solution for injection (s.c.)

2

ERYPO

Group Type: ACTIVE_COMPARATOR

ERYPO

Intervention Type: DRUG

Solution for injection (s.c.)

Interventions

HX575 recombinant human erythropoietin alfa

Solution for injection (s.c.)

Intervention Type: DRUG

ERYPO

Solution for injection (s.c.)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sandoz

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Vetter, Dr.

Role: STUDY_CHAIR

Hexal AG

Locations

Diakonissen KH Salzburg

Salzburg, , Austria

LKH Steyr

Steyr, , Austria

Krankenanstalt der Stadt Wien

Vienna, , Austria

AKH Wien

Vienna, , Austria

Sozialmedizinisches Zentrum Ost Donauspital

Vienna, , Austria

MHAT Pazardijk

Pazardzhik, , Bulgaria

MHAT Sveti Ivan Rilski

Sofia, , Bulgaria

MHAT Stara Zagora

Stara Zagora, , Bulgaria

MHAT "Sv. Anna"

Varna, , Bulgaria

Ambulance vnitrního lékarstvi

Brno, , Czechia

Nemocnice Kladno

Kladno, , Czechia

Litomyslska nemocnice, a.s.

Litomyšl, , Czechia

Nemocnice s poliklinikou v Novem Jicine

Novi Jicin, , Czechia

IKEM

Prague, , Czechia

FN Motol

Prague, , Czechia

Dialcorp, s.r.o.

Praha 4 - Michle, , Czechia

Nemocnice Prostìjov

Prostìjov, , Czechia

Nemocnice Šternberk

Sternberk, , Czechia

Nefrologická a interní amb.

Žïár N. Sázavou, , Czechia

CHU d'Amiens - Hopital Sud

Amiens, , France

CHU de Rouen - Hopital de Bois Guillaume

Bois-Guillaume, , France

Gesundheitszentrum Alzey

Alzey, , Germany

Studienzentrum Hämatologie / Onkologie / Diabetes

Aschaffenburg, , Germany

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

Aschaffenburg, , Germany

Nephrologische Praxis Bad Münder

Bad Münder am Deister, , Germany

Praxis Dr. Scharla

Bad Reichenhall, , Germany

Nephrologisches Zentrum an Stadtkrankenhaus

Bad Wildungen, , Germany

Dialyse-Centrum

Bad Windsheim, , Germany

KfH Kuratorium f. Dialyse und Nierentransplantation e.V.

Bergisch Gladbach, , Germany

Schwerpunktpraxis für Diabetologie und Nephrologie

Bernkastel-Kues, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Bischofswerda, , Germany

Dialysepraxis drs. Riedasch/Schreiber

Coesfeld, , Germany

Praxis Dr. Kraatz

Demmin, , Germany

Gemeinschaftspraxis Dr. Steffen & Dr. Perino

Dinkelsbühl, , Germany

Diabetes- und Dialysezentrum Merker, Vogt

Dormagen, , Germany

Gemeinschaftspraxis Karlstraße

Düsseldorf, , Germany

Dialysepraxis Häger, Schanze, Brause

Düsseldorf, , Germany

KfH Kuratorium f. Dialyse und Nierentransplantation e.V.

Eberswalde, , Germany

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

Essen, , Germany

Praxis Dr. Zimmermann

Essen, , Germany

Praxis Dr. Lüdemann

Falkensee, , Germany

Dialysepraxis

Friedrichroda, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Fürstenzell, , Germany

Dialysepraxis Barmbek

Hamburg, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Haßfurt, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Heringen, , Germany

Dialysezentrum

Homberg (Efze), , Germany

Gemeinschaftspraxis und Dialyse

Hürth, , Germany

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

Krefeld, , Germany

Leipziger Institut für Präventivmedizin

Leipzig, , Germany

Med Center Leipzig

Leipzig, , Germany

GDG Gemeinnützige Dialyse Gesellschaft

Leverkusen, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Ludwigshafen, , Germany

Gemeinschaftspraxis Dres. Leistikow, Hafezi und Sandner

Mannheim, , Germany

Praxis Dr. Schütterle

Marburg, , Germany

Praxis Dr. Vogel-Wagner

Mittweida, , Germany

Praxis Dr. Rose, Pohlmeier und Dr. Lammers

Münster, , Germany

Dialyse Nettetal

Nettetal, , Germany

KfH Kuratorium für dialyse und Nierentransplantation e.V.

Nördlingen, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Passau, , Germany

Praxis Dipl. med. Kosch

Pirna, , Germany

Dialysepraxis Dipl. med. Gierak & Dipl. med. Rettig

Quedlinburg, , Germany

Klinik für Nephrologie und Allgemeine Innere Medizin

Solingen, , Germany

Gemeinschaftspraxis Dr. Kirchner und Dr. Menge

Sömmerda, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Straubing, , Germany

Praxis Dr. med. Mauersberger

Villingen-Schwenningen, , Germany

Nephrologische Gemeinschaftspraxis Dr. Rensinghoff & Dr. Becker

Wattenscheid, , Germany

Kamineni Hospitals Ltd.

Hyderabaad, , India

NIZAM Institute of Medical Sciences

Hyderabaad, , India

Bombay Hospital

Indore, , India

Monilek Hospital and Research Center

Jaipur, , India

Vinaya Hospital & Research Centre

Mangalore, , India

Pulse Diagnostix Cardiac and Medical Center

Pune, , India

Kerala Institute of Medical Sciences

Trivandrum, , India

SP ZOZ Miejski Szpital Zespolony

Częstochowa, , Poland

Szpital Wojewódzki w Poznaniu

Poznan, , Poland

Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwor (Solumed SC)

Poznan, , Poland

Specjalistyczna Przychodnia Lekarska Medikard

Płock, , Poland

NZOZ NEFROLUX Sp. J. Lucjan Sobieraj, Wojciech Kaminski

Siemianowice Śląskie, , Poland

Wojewodzki Szpital Specjalistyczny nr. 1 im. Jozefa Gasinskiego

Tychy, , Poland

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

Warsaw, , Poland

NZOZ Centrum Badan Klinicznych

Wroclaw, , Poland

Centrul Medical de Diagnostic si Tratament Ambulator si Medicina Preventiva Bucuresti

Bucharest, , Romania

Institutul National de DiabetNutritie si Boli Metabolice Paulescu

Bucharest, , Romania

Institutul Clinic Fundeni

Bucharest, , Romania

Spitalul Universitar Bucuresti

Bucharest, , Romania

Spitalul Clinic Judetean Cluj

Cluj-Napoca, , Romania

County Hospital Deva

Deva, , Romania

Spitalul Clinic CI Parhon Iasi

Iași, , Romania

Dr. Gavril Curteanu Clinical Hospital

Oradea, , Romania

County Hospital Tg Mures

Tg Mures, , Romania

SC Medicali's SRL

Timișoara, , Romania

Emergency Clinical County Hospital

Timișoara, , Romania

Spitalul Judetean Timisoara

Timișoara, , Romania

Policlinica Dr. Citu

Timișoara, , Romania

Municipal medical Institution "City Hospital #1"

Barnaul, , Russia

State Healthcare Institution "Kemerova Regional Clinical Hospital"

Kemerovo, , Russia

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

Moscow, , Russia

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, , Russia

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

Moscow, , Russia

State Health Care Institution City Clinical Hospital named after SP Botkin

Moscow, , Russia

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

Nizhny Novgorod, , Russia

State Healthcare Institution "Reoublic Hospital named after VA Baranov"

Petrozavodsk, , Russia

Municipal healthcare Institution "City Clinical Hospital #2"

Pyatigorsk, , Russia

State Healthcare Institution "Ryazan Regional Cardiological Dispensary"

Ryazan, , Russia

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

Saint Petersburg, , Russia

St. Petersburg State Healthcare Institution "City Mariinsky Hospital"

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

State Institute St. Petersburg

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

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

Saratov, , Russia

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

Smolensk, , Russia

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

Tomsk, , Russia

SibMedCenter LLC

Tomsk, , Russia

Municipal Healthcare Institution "City Clinical Hospital #2"

Yaroslavl, , Russia

State Healthcare Institution of Yaroslavl region "Regional Clinical Hosptal"

Yaroslavl, , Russia

Municipal Institution "City Clinical Hospital #40"

Yekaterinburg, , Russia

State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1"

Yekaterinburg, , Russia

MEDIKOL s.r.o.

Košice, , Slovakia

SMOLKO s.r.o.

Košice, , Slovakia

FN Trnava

Trnava, , Slovakia

Countries

Austria; Bulgaria; Czechia; France; Germany; India; Poland; Romania; Russia; Slovakia

References

Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

Reference Type: DERIVED

PMID: 36791280 (View on PubMed)

Other Identifiers

2007-22-INJ-17

Identifier Type: -

Identifier Source: org_study_id