Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients

NCT ID: NCT00666835

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 478 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2006-01-31

Brief Summary

This is a double-blind, randomized, multicenter, parallel-group, equivalence study involving about 462 clinically stable hemodialysis patients aged 18 years or above suffering from anemia and treated previously with a stable dose of ERYPO® intravenously.

Detailed Description

The primary objective of this Phase III study is the evaluation of therapeutic equivalence of HX575 Hexal AG and a comparator of epoetin alfa, ERYPO® in the maintenance intravenous treatment of renal anemia. Efficacy, dosage and safety of HX575 Hexal AG in the long-term treatment were assessed.

Conditions

Anemia

Study Design

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

Study Groups

HX575 epoetin alfa Hexal AG

Eligible patients were switched from the comparator ERYPO®, to epoetin alfa HX575 Hexal AG in ratio 2:1 to be intravenously treated with HX575 in pre-filled syringes for 24 weeks (solution for injection i.v.). The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL.

Group Type: EXPERIMENTAL

HX575 epoetin alfa Hexal AG

Intervention Type: DRUG

HX575 Solution for i.v. injection Containing 1000, 2000 and 4000 IU of rh erythropoietin

ERYPO®, Janssen-Cilag

Eligible patients were randomized and continued to be treated with ERYPO® Janssen-Cilag in pre-filled syringes intravenously (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL.

Group Type: ACTIVE_COMPARATOR

ERYPO®, Janssen-Cilag

Intervention Type: DRUG

Solution for i.v. injection

Interventions

HX575 epoetin alfa Hexal AG

HX575 Solution for i.v. injection Containing 1000, 2000 and 4000 IU of rh erythropoietin

Intervention Type: DRUG

ERYPO®, Janssen-Cilag

Solution for i.v. injection

Intervention Type: DRUG

Other Intervention Names

Binocrit, Abseamed; EPREX®; Solution for i.v. injection

Eligibility Criteria

Inclusion Criteria

• Receiving dialysis for at least 6 months (3 times weekly) before screening
• Age: >=18
• Clinically stable, i.e. hemoglobin within the established range (10.0 to 13.0 g/dl) for at least 12 weeks before screening
• Stable intravenous dosage of ERYPO® three times weekly for at least 8 weeks before screening and during screening with a maximal weekly dosage of 300 IU/kg body weight (stable is defined as <25% change (up or down) in weekly dose and no change in frequency over 8 weeks prior screening and 10 weeks prior randomisation)
• Baseline hemoglobin concentration of 10.0 to 13.0 g/dl (mean of two pre-randomization pre-dialysis samples of Hb at visit -2 and visit 1)
• Serum ferritin >=100 µg/l and/or saturated transferrin levels >=20%
• C-reactive protein <15 mg/l (< 5 mg/l: normal; >= 5 mg/l < 10 mg/l: +; >=10mg/l < 100 mg/l: ++; >=100 mg/l: +++)
• Ability to follow study instructions and likely to complete all required visits
• Written informed consent of the patient

Exclusion Criteria

• Anemia of non-renal causes
• Primary hematologic disorder (e.g. myelodysplastic syndrome, sickle cell anemia, hematological malignancy, hemolytic anemia)
• Evidence of severe hepatic dysfunction (ALT and/or AST above 2 x upper limit of normal range; or gamma-GT above 3 x upper limit of normal range)
• Clinical evidence of current uncontrolled hyperparathyroidism (serum parathyroid hormone >1500 pg/mL).
• Known history of bone marrow disease
• Any red blood cell transfusion(s) during the last 12 weeks before screening or during the screening/baseline period
• Insufficient concomitant iron treatment during the last 2 months before Visit -2
• Uncontrolled hypertension, defined as a predialysis diastolic blood pressure measurement >=110 mmHg during the screening period
• Congestive heart failure [New York Heart Association (NYHA) class III and IV]
• Unstable angina pectoris, active cardiac disease, cardiac infarction during the last six months before screening
• History of blood coagulation disease
• Thrombocytopenia (platelet count <100.000/µl)
• Leukopenia (white blood cell count < 2.000/µl)
• Overt bleeding (acute or chronic bleeding within 2 months of inclusion) or hemolysis
• Evidence of acute infectious disease or serious active inflammatory states within one months before screening (Visit -2) or during the screening/baseline period
• Suspicion or known PRCA (pure red cell aplasia)
• Previously diagnosed HIV or acute hepatitis infection
• Treatment for epilepsy within the past 6 months
• Planned surgery during the next 7 months (except vascular access surgery)
• Any androgen therapy within 2 months before visit -2 and during the study
• Therapy with immunosuppressants or any drug known to affect the hematocrit within 1 month before Visit -2 and during the study
• Clinical evidence of malignant diseases
• Pregnancy, breastfeeding women or women not using adequate birth control measures
• Known history of severe drug related allergies
• Known allergy to one of the ingredients of the test or reference products or hypersensitivity to mammalian-derived products
• Simultaneous participation in another clinical study or participation in a study in the month preceding the start of this study or previously randomized in this study
• Participation in an erythropoietin study in the 3 months preceding screening (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

Hexal AG

INDUSTRY

Sponsor Role: collaborator

Sandoz

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marianne Haag-Weber, Prof.

Role: PRINCIPAL_INVESTIGATOR

Dialysezentrum Straubing, Germany

Locations

Landeskrankenhaus Feldkirch

Feldkirch, , Austria

Allgemeines Krankenhaus der Barmherzigen Brüder Graz

Graz, , Austria

Dialyseinstitut Graz GmbH

Graz, , Austria

Krankenhaus der Elisabethinen

Graz, , Austria

Universitätsklinik Innsbruck, Klinische Abteilung für Nephrologie

Innsbruck, , Austria

Allgemeines Öffentliches Krankenhaus St. Pölten, I. Med. Abteilung

Sankt Pölten, , Austria

Allgemeines öffentliches Krankenhaus Wiener Neustadt , 2. Interne Abteilung

Vienna, , Austria

Krankenanstalt Rudolfstiftung der Stadt Wien, 3. Med. Abteilung

Vienna, , Austria

Wilhelminenspital der Stadt Wien, Abt. für Nephrologie und Dialyse

Vienna, , Austria

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Aschaffenburg, , Germany

Dialysepraxis Bad Münder

Bad Münder am Deister, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Bad Nauheim, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Bamberg, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Bayreuth, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Bergisch Gladbach, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Berlin, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Bischofswerda, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Bremerhaven, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Coburg, , Germany

Dialysepraxis Drs. Riedasch/Schreiber

Coesfeld, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Deggendorf, , Germany

Dialysepraxis

Donaueschingen, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Eberswalde, , Germany

Dialysepraxis Dr. med. Stefan Holzmann

Erkelenz, , Germany

Dialysepraxis Dr. Möller, Dr. Knee

Essen, , Germany

Dialysepraxis

Freiberg, , Germany

Dialysezentrum

Freiburg im Breisgau, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Fürstenzell, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Greifswald, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Gummersbach, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Günzburg, , Germany

Praxis Dres. Sohn und Schaumann

Hamelin, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Hanover, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Haßfurt, , Germany

Dialysepraxis Dr. med. Stefan Holzmann

Heinsberg, , Germany

Praxis Dr. Kienle

Homberg (Efze), , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Ingolstadt, , Germany

KfH - Prof. Dr. med. Heide Sperschneider

Jena, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Kronach, , Germany

Dialysepraxis Dr. med. Matthias Anders

Leipzig, , Germany

Kfh Kuratorium für Dialyse & Nierentransplantation e.V., 2.Etage

Leipzig, , Germany

KfH Kuratorium für Nierentranplantation und Dialyse e.V.

Lohr, , Germany

Dialysepraxis Prof. Rob, Dr. Wilhelm u. Dr. Schümann

Lübeck, , Germany

Dialysepraxis Dr.med. H.-D. Hoffmann

Menden, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

München, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Neuried, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Nördlingen, , Germany

Gemeinschaftspraxis Dr.Steger, Dr.Böhmer, Dr.Kirpal

Nuremberg, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Oberschleißheim, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Plauen, , Germany

Dialysezentrum

Potsdam, , Germany

Praxis Dres.Hartmann, Schiele

Saarbrücken, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Straubing, , Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Sulzbach-Rosenberg, , Germany

Countries

Austria; Germany

Other Identifiers

2003-29-INJ-9

Identifier Type: -

Identifier Source: org_study_id