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Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity of Subcutaneous EPO HEXAL vs. ERYPO® in the Treatment of Anemia Associated With Chronic Renal Insufficiency in Predialysis Patients

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ClinicalTrials.gov Identifier: NCT00701714
Recruitment Status : Terminated (investigation of adverse events)
First Posted : June 19, 2008
Results First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Sandoz

Study Description
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Brief Summary:

This is a randomized, controlled, double-blind, multicenter multinational safety study involving about 300 predialysis patients aged 18 years or above suffering from anemia.

Symptomatic anemia will be corrected by s.c. application of EPO HEXAL or ERYPO® in order to achieve a hemoglobin target range of 10.0 -12.0 g/dL.


Condition or disease Intervention/treatment Phase
Anemia Chronic Renal Insufficiency Drug: HX575 recombinant human erythropoietin alfa Drug: ERYPO Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 337 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity of Subcutaneous EPO HEXAL vs. ERYPO® in the Treatment of Anemia Associated With Chronic Renal Insufficiency in Predialysis Patients
Study Start Date : September 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
HX575, EPO HEXAL
 Drug: HX575 recombinant human erythropoietin alfa
Solution for injection (s.c.)
Active Comparator: 2
ERYPO
 Drug: ERYPO
Solution for injection (s.c.)


Outcome Measures
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Primary Outcome Measures :
  1. Change in Hemoglobin Level [ Time Frame: 13 weeks ]
    Mean absolute change in hemoglobin (baseline to end of study week 13)

  2. Weekly Epoetin Dose [ Time Frame: weeks 11-13 ]
    Mean weekly epoetin dose [IU/kg] in study weeks 11-13


Secondary Outcome Measures :
  1. Immunogenicity [ Time Frame: 13 weeks ]
    Number of participants with antibody formation against Epoetin during treatment period (safety set)


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

Inclusion Criteria:

  • Known chronic renal insufficiency of at least 4 weeks duration; CKD stage at least 3 or higher
  • Male and female patients, age: >=18
  • Patients who are naïve to ESA treatment or previously ESA treated after 3 months of ESA-free period (i.v. or s.c.)
  • Patients with symptomatic anemia, defined as Hb level below 11.0 g/dL and not lower than or equal to 7.5 g/dL on at least 2 visits during the screening period
  • Adequate iron status, serum ferritin >= 100 µg/L or transferrin saturation >= 20%
  • Ability to follow study instructions and likely to complete all required visits and compliant with subcutaneous administration
  • Written informed consent of the patient.

Exclusion Criteria:

  • Anemia of non-renal causes
  • Therapy with immunosuppressants (other than corticosteroids for chronic treatment) within 3 months before screening and during the study for patients with renal allograft in place or other chronic conditions (e.g. lupus erythematosus, rheumatic arthritis)
  • Patients previously treated with chronic dialysis within the last 6 months (exception: one session of acute dialysis)
  • Patients with acute deterioration of renal function during the screening phase according to the investigator's judgment
  • Patients receiving any RBC/whole blood transfusion during the screening period
  • Primary hematological disorder (e.g. myeloma, myelodysplastic syndrome, sickle cell anemia, hematological malignancy, hemolytic anemia)
  • Evidence of uncontrolled diabetes mellitus (HbA1c > 10 % at visit -2)
  • Evidence of severe hepatic dysfunction (e.g. ALT and/or AST above 2x upper limit of normal range; or gamma-GT above 3x upper limit of normal range)
  • Clinical evidence of current uncontrolled or symptomatic hyperparathyroidism, defined as parathyroid hormone > 500 ng/L at visit -2.
  • Uncontrolled hypertension, defined as a systolic blood pressure of >= 160 mmHg and a diastolic blood pressure measurement >= 100 mmHg (average of two values with at least one day between measurements)
  • Congestive heart failure and/or angina pectoris [New York Heart Association (NYHA) class III and IV]
  • History of stroke or myocardial infarction during the last 6 months prior to visit -2
  • Ongoing treatment with phenprocoumon or other cumarin derivates
  • Thrombocytopenia (platelet count <100.000/µL) or leucopenia (white blood cell count < 2.000/µL)
  • Gastrointestinal bleeding within the last 6 months prior to visit -2 or hemolysis
  • Evidence of acute or chronic infection by a C-reactive protein value of > 30 mg/L
  • Suspicion or known PRCA (pure red cell aplasia)
  • Previously diagnosed HIV or acute hepatitis infection
  • History of epilepsy or epileptic seizures or treatment for epilepsy within the past 6 months prior to screening
  • Planned major surgery (with expected high blood loss) during the next 3 months or major surgery within the previous 3 months (except laser photocoagulation, access surgery)
  • Clinical evidence of active malignant diseases within the last 5 years (except non-melanoma skin cancer)
  • Pregnancy, breastfeeding women or women not using a highly effective birth control method (e.g. implants, injectables, combined oral contraceptives, IUD, sexual abstinence, vasectomised partner)
  • Known history of severe drug related allergies (e.g. anaphylactic shock)
  • Known allergy to one of the ingredients of the test product or hypersensitivity to mammalian-derived products
  • Known or suspicion of any non-compliance with respect to subcutaneous treatment
  • Simultaneous participation in another clinical study or participation in a study in the month preceding visit-2 or previously randomized in this study
  • Participation in another ESA study in the 3 months preceding 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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701714


Locations
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Sponsors and Collaborators
Sandoz
Investigators
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Study Chair: Andrea Vetter, Dr. Hexal AG
More Information
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Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT00701714    
Other Study ID Numbers: 2007-22-INJ-17
First Posted: June 19, 2008    Key Record Dates
Results First Posted: February 5, 2018
Last Update Posted: February 5, 2018
Last Verified: July 2017
Keywords provided by Sandoz:
Treatment
associated
with CRI
Additional relevant MeSH terms:
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Renal Insufficiency
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
 Kidney Diseases
Urologic Diseases
Epoetin Alfa
Hematinics