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Study to Evaluate the Efficacy and Safety of HX 575 vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anemia

Intervention: HX 575 Solution for i.v. injection (Drug); ERYPO®, Janssen-Cilag, Germany (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Marianne Haag-Weber, Prof., Principal Investigator, Affiliation: Dialysezentrum Straubing, Germany

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.

Clinical Details

Official title: Randomized, Double-Blind, Multicenter, Parallel-Group, Equivalence Study to Evaluate the Efficacy and Safety of HX 575 vs ERYPO for the Treatment of Anemia in Hemodialysis Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: To compare the efficacy and safety of HX 575 and ERYPO®.

Secondary outcome: Incidence and severity of all and of all drug related AEs Incidence of antibody formation against erythropoietin

Detailed description: The primary objective of this Phase III study is the evaluation of therapeutic equivalence of HX575 and a comperator epoetin alfa in the maintenance intravenous treatment of renal anemia. Efficacy, dosage and safety of HX575 in the long-term treatment were assessed.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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, St. Poelten, 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, 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, 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, Guenzburg, Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V, Gummersbach, Germany

Praxis Dres. Sohn und Schaumann, Hameln, Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V, Hannover, Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V, Haßfurt, Germany

Dialysepraxis Dr. med. Stefan Holzmann, Heinsberg, Germany

Praxis Dr. Kienle, Homberg, 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 Dialyse und Nierentransplantation e.V, Leipzig, Germany

KfH Kuratorium für Nierentranplantation und Dialyse e.V., Lohr, Germany

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

Dialysepraxis Dr.med. H.-D. Hoffmann, Menden, Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V, Muenchen, Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V, Neuried, Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V, Noerdlingen, 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, Saarbruecken, Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V, Straubing, Germany

KfH Kuratorium für Dialyse und Nierentransplantation e.V, Sulzbach-Rosenberg, Germany

Additional Information

Starting date: April 2004
Last updated: April 24, 2008

Page last updated: August 23, 2015

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