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AzTrials

AnemiaPhase 3NCT00701714

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

A Phase 3 study testing HX575 recombinant human erythropoietin alfa and ERYPO in people with Anemia and Chronic Renal Insufficiency, run by Sandoz at 123 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia, Chronic Renal Insufficiency
What is being tested?
HX575 recombinant human erythropoietin alfa and ERYPO
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
337 participants
Where
123 sitesin 10 countries
Study dates
Sep 2007to Jan 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 28Show fewer
  • 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.

Trial locations and contacts

123 sites in 10 countries.

123 sites in 10 countries

Germany46 sites

  • Gesundheitszentrum Alzey

    Alzey, 55232

  • Studienzentrum Hämatologie / Onkologie / Diabetes

    Aschaffenburg, 63739

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

    Aschaffenburg, 63741

  • Nephrologische Praxis Bad Münder

    Bad Münder am Deister, 31848

  • Praxis Dr. Scharla

    Bad Reichenhall, 83435

  • Nephrologisches Zentrum an Stadtkrankenhaus

    Bad Wildungen, 34537

  • Dialyse-Centrum

    Bad Windsheim, 91438

  • KfH Kuratorium f. Dialyse und Nierentransplantation e.V.

    Bergisch Gladbach, 51465

  • Schwerpunktpraxis für Diabetologie und Nephrologie

    Bernkastel-Kues, 54470

  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.

    Bischofswerda, 01877

  • Dialysepraxis drs. Riedasch/Schreiber

    Coesfeld, 48653

  • Praxis Dr. Kraatz

    Demmin, 17109

  • Gemeinschaftspraxis Dr. Steffen & Dr. Perino

    Dinkelsbühl, 91550

  • Diabetes- und Dialysezentrum Merker, Vogt

    Dormagen, 41539

  • Gemeinschaftspraxis Karlstraße

    Düsseldorf, 40210

  • Dialysepraxis Häger, Schanze, Brause

    Düsseldorf, 40211

  • KfH Kuratorium f. Dialyse und Nierentransplantation e.V.

    Eberswalde, 16225

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

    Essen, 45127

  • Praxis Dr. Zimmermann

    Essen, 45136

  • Praxis Dr. Lüdemann

    Falkensee, 14612

  • Dialysepraxis

    Friedrichroda, 99894

  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.

    Fürstenzell, 94081

  • Dialysepraxis Barmbek

    Hamburg, 22297

  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.

    Haßfurt, 97437

  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.

    Heringen, 36266

  • Dialysezentrum

    Homberg (Efze), 34576

  • Gemeinschaftspraxis und Dialyse

    Hürth, 50354

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

    Krefeld, 47798

  • Leipziger Institut für Präventivmedizin

    Leipzig, 04103

  • Med Center Leipzig

    Leipzig, 04107

  • GDG Gemeinnützige Dialyse Gesellschaft

    Leverkusen, 51373

  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.

    Ludwigshafen, 67059

  • Gemeinschaftspraxis Dres. Leistikow, Hafezi und Sandner

    Mannheim, 68309

  • Praxis Dr. Schütterle

    Marburg, 35043

  • Praxis Dr. Vogel-Wagner

    Mittweida, 09648

  • Praxis Dr. Rose, Pohlmeier und Dr. Lammers

    Münster, 48145

  • Dialyse Nettetal

    Nettetal, 41334

  • KfH Kuratorium für dialyse und Nierentransplantation e.V.

    Nördlingen, 86720

  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.

    Passau, 94032

  • Praxis Dipl. med. Kosch

    Pirna, 01796

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

    Quedlinburg, 06484

  • Klinik für Nephrologie und Allgemeine Innere Medizin

    Solingen, 42653

  • Gemeinschaftspraxis Dr. Kirchner und Dr. Menge

    Sömmerda, 99610

  • KfH Kuratorium für Dialyse und Nierentransplantation e.V.

    Straubing, 94315

  • Praxis Dr. med. Mauersberger

    Villingen-Schwenningen, 78054

  • Nephrologische Gemeinschaftspraxis Dr. Rensinghoff & Dr. Becker

    Wattenscheid, 44866

Other trials in Germany

Russia25 sites

  • Municipal medical Institution "City Hospital #1"

    Barnaul, 656099

  • State Healthcare Institution "Kemerova Regional Clinical Hospital"

    Kemerovo, 650066

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

    Moscow, 105203

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

    Moscow, 115432

  • State Health Care Institution City Clinical Hospital named after SP Botkin

    Moscow, 125284

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

    Nizhny Novgorod, 603126

  • State Healthcare Institution "Reoublic Hospital named after VA Baranov"

    Petrozavodsk, 185019

  • Municipal healthcare Institution "City Clinical Hospital #2"

    Pyatigorsk, 357538

  • State Healthcare Institution "Ryazan Regional Cardiological Dispensary"

    Ryazan, 390026

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

    Saint Petersburg, 191015

  • St. Petersburg State Healthcare Institution "City Mariinsky Hospital"

    Saint Petersburg, 191104

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

    Saint Petersburg, 192242

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

    Saint Petersburg, 194358

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

    Saint Petersburg, 195067

  • State Institute St. Petersburg

    Saint Petersburg, 195067

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

    Saint Petersburg, 197022

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

    Saratov, 410053

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

    Smolensk, 214018

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

    Tomsk, 634012

  • SibMedCenter LLC

    Tomsk, 634041

  • Municipal Healthcare Institution "City Clinical Hospital #2"

    Yaroslavl, 150010

  • State Healthcare Institution of Yaroslavl region "Regional Clinical Hosptal"

    Yaroslavl, 150062

  • Municipal Institution "City Clinical Hospital #40"

    Yekaterinburg, 620102

  • State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1"

    Yekaterinburg, 620102

Other trials in Russia

Romania13 sites

  • Centrul Medical de Diagnostic si Tratament Ambulator si Medicina Preventiva Bucuresti

    Bucharest, 011794

  • Institutul National de DiabetNutritie si Boli Metabolice Paulescu

    Bucharest, 020475

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Spitalul Universitar Bucuresti

    Bucharest, 050098

  • Spitalul Clinic Judetean Cluj

    Cluj-Napoca, 400 006

  • County Hospital Deva

    Deva, 330084

  • Spitalul Clinic CI Parhon Iasi

    Iași, 700503

  • Dr. Gavril Curteanu Clinical Hospital

    Oradea, 410469

  • County Hospital Tg Mures

    Tg Mures, 540103

  • SC Medicali's SRL

    Timișoara, 300359

  • Emergency Clinical County Hospital

    Timișoara, 300736

  • Spitalul Judetean Timisoara

    Timișoara, 300736

  • Policlinica Dr. Citu

    Timișoara, 300766

Other trials in Romania

Czechia10 sites

  • Ambulance vnitrního lékarstvi

    Brno, 61500

  • Nemocnice Kladno

    Kladno, 27259

  • Litomyslska nemocnice, a.s.

    Litomyšl, 57014

  • Nemocnice s poliklinikou v Novem Jicine

    Novi Jicin, 741 01

  • IKEM

    Prague, 14021

  • FN Motol

    Prague, 15006

  • Dialcorp, s.r.o.

    Praha 4 - Michle, 140 00

  • Nemocnice Prostìjov

    Prostìjov, 79604

  • Nemocnice Šternberk

    Sternberk, 78501

  • Nefrologická a interní amb.

    Žïár N. Sázavou, 591 01

Other trials in Czechia

Poland8 sites

  • SP ZOZ Miejski Szpital Zespolony

    Częstochowa, 42200

  • Specjalistyczna Przychodnia Lekarska Medikard

    Płock, 09-402

  • Szpital Wojewódzki w Poznaniu

    Poznan, 60-479

  • Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwor (Solumed SC)

    Poznan, 60-539

  • NZOZ NEFROLUX Sp. J. Lucjan Sobieraj, Wojciech Kaminski

    Siemianowice Śląskie, 41100

  • Wojewodzki Szpital Specjalistyczny nr. 1 im. Jozefa Gasinskiego

    Tychy, 43-100

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

    Warsaw, 03401

  • NZOZ Centrum Badan Klinicznych

    Wroclaw, 50-349

Other trials in Poland

India7 sites

  • Kamineni Hospitals Ltd.

    Hyderabaad, 500068

  • NIZAM Institute of Medical Sciences

    Hyderabaad, 500082

  • Bombay Hospital

    Indore, 452010

  • Monilek Hospital and Research Center

    Jaipur, 302004

  • Vinaya Hospital & Research Centre

    Mangalore, 575003

  • Pulse Diagnostix Cardiac and Medical Center

    Pune, 411001

  • Kerala Institute of Medical Sciences

    Trivandrum, 695029

Other trials in India

Austria5 sites

  • Diakonissen KH Salzburg

    Salzburg, 5020

  • LKH Steyr

    Steyr, 4400

  • Krankenanstalt der Stadt Wien

    Vienna, 1030

  • AKH Wien

    Vienna, 1090

  • Sozialmedizinisches Zentrum Ost Donauspital

    Vienna, 1220

Other trials in Austria

Bulgaria4 sites

  • MHAT Pazardijk

    Pazardzhik, 4400

  • MHAT Sveti Ivan Rilski

    Sofia, 1431

  • MHAT Stara Zagora

    Stara Zagora, 6003

  • MHAT "Sv. Anna"

    Varna, 9002

Other trials in Bulgaria

Slovakia3 sites

  • MEDIKOL s.r.o.

    Košice, 040 01

  • SMOLKO s.r.o.

    Košice, 04001

  • FN Trnava

    Trnava, 917 75

Other trials in Slovakia

France2 sites

  • CHU d'Amiens - Hopital Sud

    Amiens, 80054

  • CHU de Rouen - Hopital de Bois Guillaume

    Bois-Guillaume, 76230

Other trials in France

About this study

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.

Being tested
HX575 recombinant human erythropoietin alfa, ERYPO
Keywords
Treatment, associated, with CRI
Medical subject headings
Anemia, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HX575 recombinant human erythropoietin alfaDrug

    Solution for injection (s.c.)

  • ERYPODrug

    Solution for injection (s.c.)

Study groups in NCT00701714
Study groupRoleWhat they receive
1ExperimentalHX575, EPO HEXAL
Receives: Drug: HX575 recombinant human erythropoietin alfa
2Active comparatorERYPO
Receives: Drug: ERYPO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Hemoglobin Level

    Mean absolute change in hemoglobin (baseline to end of study week 13)

    Measured: 13 weeks

  2. Weekly Epoetin Dose

    Mean weekly epoetin dose [IU/kg] in study weeks 11-13

    Measured: weeks 11-13

Secondary outcomes (1)

  1. Immunogenicity

    Number of participants with antibody formation against Epoetin during treatment period (safety set)

    Measured: 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2008 (estimated)
  2. Study startSep 2007
  3. Primary completionJul 2009
  4. Study completionJan 2010

Why it stopped: investigation of adverse events

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
337 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00701714
Sponsor's protocol ID
2007-22-INJ-17
Status last verified
Jul 2017
First submitted
17 Jun 2008
Last updated
5 Feb 2018
Data monitoring committee
No

Publications

  • 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.

    PubMed 36791280

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HX575 recombinant human erythropoietin alfa and ERYPO in people with Anemia and Chronic Renal Insufficiency, run by Sandoz at 123 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in Germany, Russia, Romania, Czechia, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hemoglobin Level (time frame: 13 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00701714, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.

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