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

This study has been completed.
Hexal AG
Information provided by (Responsible Party):
Sandoz Identifier:
First received: April 23, 2008
Last updated: October 21, 2016
Last verified: October 2016
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.

Condition Intervention Phase
Anemia Drug: HX575 Solution for i.v. injection Drug: ERYPO®, Janssen-Cilag, Germany Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • To compare the efficacy and safety of HX 575 and ERYPO®. [ Time Frame: 28 weeks ]

Secondary Outcome Measures:
  • Incidence and severity of all and of all drug related AEs Incidence of antibody formation against erythropoietin [ Time Frame: 56 weeks ]

Enrollment: 462
Study Start Date: April 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HX575 epoetin alfa Hexal AG
Eligible patients were switched from the comparator to HX575 (erythropoietin alfa) in ratio 2:1 to be intravenously (solution for injection i.v.) treated with HX575 in pre-filled syringes 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: HX575 Solution for i.v. injection
HX575 Solution for i.v. injection Containing 1000, 2000 and 4000 IU of rh erythropoietin
Other Name: Binocrit, Abseamed
Active Comparator: ERYPO®, Janssen-Cilag
Eligible patients were randomized and continued to be treated with ERYPO® 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, Germany
Solution for i.v. injection
Other Names:
  • EPREX®
  • Solution for i.v. injection

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00666835

  Show 54 Study Locations
Sponsors and Collaborators
Hexal AG
Principal Investigator: Marianne Haag-Weber, Prof. Dialysezentrum Straubing, Germany
  More Information

Responsible Party: Sandoz Identifier: NCT00666835     History of Changes
Other Study ID Numbers: 2003-29-INJ-9
Study First Received: April 23, 2008
Last Updated: October 21, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sandoz:
Treatment of anemia in hemodialysis patients

Additional relevant MeSH terms:
Hematologic Diseases
Pharmaceutical Solutions
Epoetin Alfa
Hematinics processed this record on July 21, 2017