Clinical trial NCT00666835: Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients
Official title: Randomized, Double-blind, Multicenter, Parallel-group, Equivalence Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: Treatment of anemia in hemodialysis patients
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
Collaborators: name: Hexal AG
First posted: 2008-04-25
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To Compare the Efficacy of HX575 Hexal AG and ERYPO® Janssen-Cilag.
timeFrame: 28 weeks
Secondary outcomes:
measure: Mean Absolute Change in Hemoglobin Level From the Screening/Baseline Period to the Evaluation Period - ITT Population
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Graz
country: Austria
facility: Allgemeines Krankenhaus der Barmherzigen Brüder Graz
city: Graz
country: Austria
facility: Dialyseinstitut Graz GmbH
city: Graz
country: Austria
facility: Krankenhaus der Elisabethinen
city: Innsbruck
country: Austria
facility: Universitätsklinik Innsbruck, Klinische Abteilung für Nephrologie
city: St. Poelten
country: Austria
facility: Allgemeines Öffentliches Krankenhaus St. Pölten, I. Med. Abteilung
city: Vienna
country: Austria
facility: Allgemeines öffentliches Krankenhaus Wiener Neustadt , 2. Interne Abteilung
city: Vienna
country: Austria
facility: Krankenanstalt Rudolfstiftung der Stadt Wien, 3. Med. Abteilung
city: Vienna
country: Austria
facility: Wilhelminenspital der Stadt Wien, Abt. für Nephrologie und Dialyse
city: Aschaffenburg
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Bad Münder
country: Germany
facility: Dialysepraxis Bad Münder
city: Bad Nauheim
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Bamberg
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Bayreuth
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Bergisch Gladbach
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Berlin
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Bischofswerda
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
city: Bremerhaven
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
city: Coburg
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
city: Coesfeld
country: Germany
facility: Dialysepraxis Drs. Riedasch/Schreiber
city: Deggendorf
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Donaueschingen
country: Germany
facility: Dialysepraxis
city: Eberswalde
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Erkelenz
country: Germany
facility: Dialysepraxis Dr. med. Stefan Holzmann
city: Essen
country: Germany
facility: Dialysepraxis Dr. Möller, Dr. Knee
city: Freiberg
country: Germany
facility: Dialysepraxis
city: Freiburg
country: Germany
facility: Dialysezentrum
city: Fürstenzell
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Greifswald
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Guenzburg
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Gummersbach
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Hameln
country: Germany
facility: Praxis Dres. Sohn und Schaumann
city: Hannover
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Haßfurt
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Heinsberg
country: Germany
facility: Dialysepraxis Dr. med. Stefan Holzmann
city: Homberg
country: Germany
facility: Praxis Dr. Kienle
city: Ingolstadt
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Jena
country: Germany
facility: KfH - Prof. Dr. med. Heide Sperschneider
city: Kronach
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Leipzig
country: Germany
facility: Dialysepraxis Dr. med. Matthias Anders
city: Leipzig
country: Germany
facility: Kfh Kuratorium für Dialyse & Nierentransplantation e.V., 2.Etage
city: Lohr
country: Germany
facility: KfH Kuratorium für Nierentranplantation und Dialyse e.V.
city: Luebeck
country: Germany
facility: Dialysepraxis Prof. Rob, Dr. Wilhelm u. Dr. Schümann
city: Menden
country: Germany
facility: Dialysepraxis Dr.med. H.-D. Hoffmann
city: Muenchen
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Neuried
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Noerdlingen
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Nuremberg
country: Germany
facility: Gemeinschaftspraxis Dr.Steger, Dr.Böhmer, Dr.Kirpal
city: Oberschleißheim
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Plauen
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
city: Potsdam
country: Germany
facility: Dialysezentrum
city: Saarbruecken
country: Germany
facility: Praxis Dres.Hartmann, Schiele
city: Straubing
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
city: Sulzbach-Rosenberg
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V
Study officials:
affiliation: Dialysezentrum Straubing, Germany
name: Marianne Haag-Weber, Prof.
role: PRINCIPAL_INVESTIGATOR
References: