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

NCT00666835 | Completed Phase 3 Results

• 1 other identifier: 2003-29-INJ-9
• Study Type: interventional
• Target: 478
• Locations: 2 countries
• Sites: 54

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.

Conditions

Anemia

Keywords

Treatment of anemia in hemodialysis patients

Outcome Measures

Primary Outcomes (1)

• To Compare the Efficacy of HX575 Hexal AG and ERYPO® Janssen-Cilag.

  Primary endpoint was the mean absolute change in Hb level between the screening/baseline and the evaluation period. A two-sided 95 % confidence interval for the difference in mean change (mean of evaluation period - mean of screening/baseline period) in Hb between epoetin alfa HX575 Hexal AG and ERYPO® Janssen-Cilag was computed. The difference was estimated from an analysis of a co-variance model including factors treatment, center, mean baseline Hb (\<11.5 and ≥11.5 g/dL) as factors and change of the mean weekly dose from screening/baseline to the evaluation period (of HX575 epoetin alfa Hexal AG or ERYPO® Janssen-Cilag) as a covariate. HX575 Hexal AG was considered at least as good as ERYPO® Janssen-Cilag if the 95 % confidence interval of the difference in mean changes in Hb levels between HX575 Hexal AG and ERYPO® Janssen-Cilag lied entirely within the interval \[-0.5 g/dL; 0.5 g/dL\]. Primary Endpoint was analyzed based on intent-to-treat (ITT) population.

  28 weeks

Secondary Outcomes (1)

• Mean Absolute Change in Hemoglobin Level From the Screening/Baseline Period to the Evaluation Period - ITT Population

  28 weeks

Study Arms (2)

HX575 epoetin alfa Hexal AG

EXPERIMENTAL

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.

Drug: HX575 epoetin alfa Hexal AG

ERYPO®, Janssen-Cilag

ACTIVE COMPARATOR

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.

Drug: ERYPO®, Janssen-Cilag

Interventions

HX575 epoetin alfa Hexal AG DRUG

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

Also known as: Binocrit, Abseamed

HX575 epoetin alfa Hexal AG

ERYPO®, Janssen-Cilag DRUG

Solution for i.v. injection

Also known as: EPREX®, Solution for i.v. injection

ERYPO®, Janssen-Cilag

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Sandoz: lead
• Hexal AG: collaborator

Study Sites (54)

Landeskrankenhaus Feldkirch

Feldkirch, Austria

Location

Allgemeines Krankenhaus der Barmherzigen Brüder Graz

Graz, Austria

Location

Dialyseinstitut Graz GmbH

Graz, Austria

Location

Krankenhaus der Elisabethinen

Graz, Austria

Location

Universitätsklinik Innsbruck, Klinische Abteilung für Nephrologie

Innsbruck, Austria

Location

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

Sankt Pölten, Austria

Location

Allgemeines öffentliches Krankenhaus Wiener Neustadt , 2. Interne Abteilung

Vienna, Austria

Location

Krankenanstalt Rudolfstiftung der Stadt Wien, 3. Med. Abteilung

Vienna, Austria

Location

Wilhelminenspital der Stadt Wien, Abt. für Nephrologie und Dialyse

Vienna, Austria

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Aschaffenburg, Germany

Location

Dialysepraxis Bad Münder

Bad Münder am Deister, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Bad Nauheim, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Bamberg, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Bayreuth, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Bergisch Gladbach, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Berlin, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Bischofswerda, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Bremerhaven, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Coburg, Germany

Location

Dialysepraxis Drs. Riedasch/Schreiber

Coesfeld, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Deggendorf, Germany

Location

Dialysepraxis

Donaueschingen, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Eberswalde, Germany

Location

Dialysepraxis Dr. med. Stefan Holzmann

Erkelenz, Germany

Location

Dialysepraxis Dr. Möller, Dr. Knee

Essen, Germany

Location

Dialysepraxis

Freiberg, Germany

Location

Dialysezentrum

Freiburg im Breisgau, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Fürstenzell, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Greifswald, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Gummersbach, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Günzburg, Germany

Location

Praxis Dres. Sohn und Schaumann

Hamelin, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Hanover, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Haßfurt, Germany

Location

Dialysepraxis Dr. med. Stefan Holzmann

Heinsberg, Germany

Location

Praxis Dr. Kienle

Homberg (Efze), Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Ingolstadt, Germany

Location

KfH - Prof. Dr. med. Heide Sperschneider

Jena, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Kronach, Germany

Location

Dialysepraxis Dr. med. Matthias Anders

Leipzig, Germany

Location

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

Leipzig, Germany

Location

KfH Kuratorium für Nierentranplantation und Dialyse e.V.

Lohr, Germany

Location

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

Lübeck, Germany

Location

Dialysepraxis Dr.med. H.-D. Hoffmann

Menden, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

München, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Neuried, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Nördlingen, Germany

Location

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

Nuremberg, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Oberschleißheim, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V.

Plauen, Germany

Location

Dialysezentrum

Potsdam, Germany

Location

Praxis Dres.Hartmann, Schiele

Saarbrücken, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Straubing, Germany

Location

KfH Kuratorium für Dialyse und Nierentransplantation e.V

Sulzbach-Rosenberg, Germany

Location

MeSH Terms

Conditions

Anemia

Interventions

Epoetin Alfa; Solutions

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Pharmaceutical Preparations

Results Point of Contact

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

biopharma.clinicaltrials@sandoz.com

0049 80244760

Study Officials

• Marianne Haag-Weber, Prof.

  Dialysezentrum Straubing, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: April 23, 2008
• First Posted: April 25, 2008
• Study Start: April 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: July 3, 2023
• Results First Posted: August 2, 2017

Record last verified: 2023-06

Locations

AU (9); DE (45)