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

July 13, 2017 updated by: Sandoz

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

337

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
HX575, EPO HEXAL
Drug: HX575 recombinant human erythropoietin alfa
Solution for injection (s.c.)
ACTIVE_COMPARATOR: 2
ERYPO
Drug: ERYPO
Solution for injection (s.c.)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity
Time Frame: 13 weeks
Number of participants with antibody formation against Epoetin during treatment period (safety set)
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Investigators

  • Study Chair: Andrea Vetter, Dr., Hexal AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

July 1, 2009

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (ESTIMATE)

June 19, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2018

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-22-INJ-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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