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.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00666835
First received: April 23, 2008
Last updated: April 24, 2008
Last verified: April 2008
  Purpose

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: HX 575 Solution for i.v. injection
Drug: ERYPO®, Janssen-Cilag, Germany
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Novartis:

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

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

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
Active Comparator: 1
HX575
Drug: HX 575 Solution for i.v. injection
HX 575 Solution for i.v. injection Containing 1000, 2000 and 4000 IU of rh erythropoietin
Other Name: Binocrit
Active Comparator: 2 Drug: ERYPO®, Janssen-Cilag, Germany
Solution for i.v. injection
Other Names:
  • ERYPO®, Janssen-Cilag, Germany
  • 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 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666835

  Show 55 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Marianne Haag-Weber, Prof. Dialysezentrum Straubing, Germany
  More Information

No publications provided

Responsible Party: Hexal AG
ClinicalTrials.gov Identifier: NCT00666835     History of Changes
Other Study ID Numbers: 2003-29-INJ-9
Study First Received: April 23, 2008
Last Updated: April 24, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Office for Safety in Health Care

Keywords provided by Novartis:
Treatment of anemia in hemodialysis patients

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Pharmaceutical Solutions
Epoetin alfa
Therapeutic Uses
Pharmacologic Actions
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on September 22, 2014