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

NCT00701714 | Terminated Phase 3 Results

• 1 other identifier: 2007-22-INJ-17
• Study Type: interventional
• Target: 337
• Locations: 10 countries
• Sites: 123

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

Keywords

Treatment; associated; with CRI

Outcome Measures

Primary Outcomes (2)

• Change in Hemoglobin Level

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

  13 weeks

• Weekly Epoetin Dose

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

  weeks 11-13

Secondary Outcomes (1)

• Immunogenicity

  13 weeks

Study Arms (2)

1

EXPERIMENTAL

HX575, EPO HEXAL

Drug: HX575 recombinant human erythropoietin alfa

2

ACTIVE COMPARATOR

ERYPO

Drug: ERYPO

Interventions

HX575 recombinant human erythropoietin alfa DRUG

Solution for injection (s.c.)

1

ERYPO DRUG

Solution for injection (s.c.)

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sandoz: lead

Study Sites (123)

Diakonissen KH Salzburg

Salzburg, 5020, Austria

Location

LKH Steyr

Steyr, 4400, Austria

Location

Krankenanstalt der Stadt Wien

Vienna, 1030, Austria

Location

AKH Wien

Vienna, 1090, Austria

Location

Sozialmedizinisches Zentrum Ost Donauspital

Vienna, 1220, Austria

Location

MHAT Pazardijk

Pazardzhik, 4400, Bulgaria

Location

MHAT Sveti Ivan Rilski

Sofia, 1431, Bulgaria

Location

MHAT Stara Zagora

Stara Zagora, 6003, Bulgaria

Location

MHAT "Sv. Anna"

Varna, 9002, Bulgaria

Location

Ambulance vnitrního lékarstvi

Brno, 61500, Czechia

Location

Nemocnice Kladno

Kladno, 27259, Czechia

Location

Litomyslska nemocnice, a.s.

Litomyšl, 57014, Czechia

Location

Nemocnice s poliklinikou v Novem Jicine

Novi Jicin, 741 01, Czechia

Location

IKEM

Prague, 14021, Czechia

Location

FN Motol

Prague, 15006, Czechia

Location

Dialcorp, s.r.o.

Praha 4 - Michle, 140 00, Czechia

Location

Nemocnice Prostìjov

Prostìjov, 79604, Czechia

Location

Nemocnice Šternberk

Sternberk, 78501, Czechia

Location

Nefrologická a interní amb.

Žïár N. Sázavou, 591 01, Czechia

Location

CHU d'Amiens - Hopital Sud

Amiens, 80054, France

Location

CHU de Rouen - Hopital de Bois Guillaume

Bois-Guillaume, 76230, France

Location

Gesundheitszentrum Alzey

Alzey, 55232, Germany

Location

Studienzentrum Hämatologie / Onkologie / Diabetes

Aschaffenburg, 63739, Germany

Location

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

Aschaffenburg, 63741, Germany

Location

Nephrologische Praxis Bad Münder

Bad Münder am Deister, 31848, Germany

Location

Praxis Dr. Scharla

Bad Reichenhall, 83435, Germany

Location

Nephrologisches Zentrum an Stadtkrankenhaus

Bad Wildungen, 34537, Germany

Location

Dialyse-Centrum

Bad Windsheim, 91438, Germany

Location

KfH Kuratorium f. Dialyse und Nierentransplantation e.V.

Bergisch Gladbach, 51465, Germany

Location

Schwerpunktpraxis für Diabetologie und Nephrologie

Bernkastel-Kues, 54470, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Bischofswerda, 01877, Germany

Location

Dialysepraxis drs. Riedasch/Schreiber

Coesfeld, 48653, Germany

Location

Praxis Dr. Kraatz

Demmin, 17109, Germany

Location

Gemeinschaftspraxis Dr. Steffen & Dr. Perino

Dinkelsbühl, 91550, Germany

Location

Diabetes- und Dialysezentrum Merker, Vogt

Dormagen, 41539, Germany

Location

Gemeinschaftspraxis Karlstraße

Düsseldorf, 40210, Germany

Location

Dialysepraxis Häger, Schanze, Brause

Düsseldorf, 40211, Germany

Location

KfH Kuratorium f. Dialyse und Nierentransplantation e.V.

Eberswalde, 16225, Germany

Location

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

Essen, 45127, Germany

Location

Praxis Dr. Zimmermann

Essen, 45136, Germany

Location

Praxis Dr. Lüdemann

Falkensee, 14612, Germany

Location

Dialysepraxis

Friedrichroda, 99894, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Fürstenzell, 94081, Germany

Location

Dialysepraxis Barmbek

Hamburg, 22297, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Haßfurt, 97437, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Heringen, 36266, Germany

Location

Dialysezentrum

Homberg (Efze), 34576, Germany

Location

Gemeinschaftspraxis und Dialyse

Hürth, 50354, Germany

Location

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

Krefeld, 47798, Germany

Location

Leipziger Institut für Präventivmedizin

Leipzig, 04103, Germany

Location

Med Center Leipzig

Leipzig, 04107, Germany

Location

GDG Gemeinnützige Dialyse Gesellschaft

Leverkusen, 51373, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Ludwigshafen, 67059, Germany

Location

Gemeinschaftspraxis Dres. Leistikow, Hafezi und Sandner

Mannheim, 68309, Germany

Location

Praxis Dr. Schütterle

Marburg, 35043, Germany

Location

Praxis Dr. Vogel-Wagner

Mittweida, 09648, Germany

Location

Praxis Dr. Rose, Pohlmeier und Dr. Lammers

Münster, 48145, Germany

Location

Dialyse Nettetal

Nettetal, 41334, Germany

Location

KfH Kuratorium für dialyse und Nierentransplantation e.V.

Nördlingen, 86720, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Passau, 94032, Germany

Location

Praxis Dipl. med. Kosch

Pirna, 01796, Germany

Location

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

Quedlinburg, 06484, Germany

Location

Klinik für Nephrologie und Allgemeine Innere Medizin

Solingen, 42653, Germany

Location

Gemeinschaftspraxis Dr. Kirchner und Dr. Menge

Sömmerda, 99610, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Straubing, 94315, Germany

Location

Praxis Dr. med. Mauersberger

Villingen-Schwenningen, 78054, Germany

Location

Nephrologische Gemeinschaftspraxis Dr. Rensinghoff & Dr. Becker

Wattenscheid, 44866, Germany

Location

Kamineni Hospitals Ltd.

Hyderabaad, 500068, India

Location

NIZAM Institute of Medical Sciences

Hyderabaad, 500082, India

Location

Bombay Hospital

Indore, 452010, India

Location

Monilek Hospital and Research Center

Jaipur, 302004, India

Location

Vinaya Hospital & Research Centre

Mangalore, 575003, India

Location

Pulse Diagnostix Cardiac and Medical Center

Pune, 411001, India

Location

Kerala Institute of Medical Sciences

Trivandrum, 695029, India

Location

SP ZOZ Miejski Szpital Zespolony

Częstochowa, 42200, Poland

Location

Szpital Wojewódzki w Poznaniu

Poznan, 60-479, Poland

Location

Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwor (Solumed SC)

Poznan, 60-539, Poland

Location

Specjalistyczna Przychodnia Lekarska Medikard

Płock, 09-402, Poland

Location

NZOZ NEFROLUX Sp. J. Lucjan Sobieraj, Wojciech Kaminski

Siemianowice Śląskie, 41100, Poland

Location

Wojewodzki Szpital Specjalistyczny nr. 1 im. Jozefa Gasinskiego

Tychy, 43-100, Poland

Location

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

Warsaw, 03401, Poland

Location

NZOZ Centrum Badan Klinicznych

Wroclaw, 50-349, Poland

Location

Centrul Medical de Diagnostic si Tratament Ambulator si Medicina Preventiva Bucuresti

Bucharest, 011794, Romania

Location

Institutul National de DiabetNutritie si Boli Metabolice Paulescu

Bucharest, 020475, Romania

Location

Institutul Clinic Fundeni

Bucharest, 022328, Romania

Location

Spitalul Universitar Bucuresti

Bucharest, 050098, Romania

Location

Spitalul Clinic Judetean Cluj

Cluj-Napoca, 400 006, Romania

Location

County Hospital Deva

Deva, 330084, Romania

Location

Spitalul Clinic CI Parhon Iasi

Iași, 700503, Romania

Location

Dr. Gavril Curteanu Clinical Hospital

Oradea, 410469, Romania

Location

County Hospital Tg Mures

Tg Mures, 540103, Romania

Location

SC Medicali's SRL

Timișoara, 300359, Romania

Location

Emergency Clinical County Hospital

Timișoara, 300736, Romania

Location

Spitalul Judetean Timisoara

Timișoara, 300736, Romania

Location

Policlinica Dr. Citu

Timișoara, 300766, Romania

Location

Municipal medical Institution "City Hospital #1"

Barnaul, 656099, Russia

Location

State Healthcare Institution "Kemerova Regional Clinical Hospital"

Kemerovo, 650066, Russia

Location

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

Moscow, 105203, Russia

Location

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, Russia

Location

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

Moscow, 115432, Russia

Location

State Health Care Institution City Clinical Hospital named after SP Botkin

Moscow, 125284, Russia

Location

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

Nizhny Novgorod, 603126, Russia

Location

State Healthcare Institution "Reoublic Hospital named after VA Baranov"

Petrozavodsk, 185019, Russia

Location

Municipal healthcare Institution "City Clinical Hospital #2"

Pyatigorsk, 357538, Russia

Location

State Healthcare Institution "Ryazan Regional Cardiological Dispensary"

Ryazan, 390026, Russia

Location

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

Saint Petersburg, 191015, Russia

Location

St. Petersburg State Healthcare Institution "City Mariinsky Hospital"

Saint Petersburg, 191104, Russia

Location

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

Saint Petersburg, 192242, Russia

Location

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

Saint Petersburg, 194358, Russia

Location

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

Saint Petersburg, 195067, Russia

Location

State Institute St. Petersburg

Saint Petersburg, 195067, Russia

Location

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

Saint Petersburg, 197022, Russia

Location

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

Saratov, 410053, Russia

Location

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

Smolensk, 214018, Russia

Location

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

Tomsk, 634012, Russia

Location

SibMedCenter LLC

Tomsk, 634041, Russia

Location

Municipal Healthcare Institution "City Clinical Hospital #2"

Yaroslavl, 150010, Russia

Location

State Healthcare Institution of Yaroslavl region "Regional Clinical Hosptal"

Yaroslavl, 150062, Russia

Location

Municipal Institution "City Clinical Hospital #40"

Yekaterinburg, 620102, Russia

Location

State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1"

Yekaterinburg, 620102, Russia

Location

MEDIKOL s.r.o.

Košice, 040 01, Slovakia

Location

SMOLKO s.r.o.

Košice, 04001, Slovakia

Location

FN Trnava

Trnava, 917 75, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 36791280 DERIVED

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Biopharmaceutical Clinical Development, Strategic Planning
• Organization: Sandoz

biopharma.clinicaltrials@sandoz.com

0049 80244760

Study Officials

• Andrea Vetter, Dr.

  Hexal AG

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: September 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: January 1, 2010
• Last Updated: February 5, 2018
• Results First Posted: February 5, 2018

Record last verified: 2017-07

Locations

AU (5); BU (4); SL (3); FR (2); CZ (10); IN (7); RU (25); PL (8); RO (13); DE (46)