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

This study has been terminated.
(investigation of adverse events)
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00701714
First received: June 17, 2008
Last updated: February 10, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Anemia
Chronic Renal Insufficiency
Drug: HX575 recombinant human erythropoietin alfa
Drug: ERYPO
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, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • change in hemoglobin level [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • incidence of antibody formation [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: September 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00701714

  Show 123 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Andrea Vetter, Dr. Hexal AG
  More Information

No publications provided

Responsible Party: Hexal AG
ClinicalTrials.gov Identifier: NCT00701714     History of Changes
Other Study ID Numbers: 2007-22-INJ-17
Study First Received: June 17, 2008
Last Updated: February 10, 2010
Health Authority: Austria: Agency for Health and Food Safety
Germany: Federal Institute for Drugs and Medical Devices
Romania: National Medicines Agency
Czech Republic: State Institute for Drug Control
Slovakia: State Institute for Drug Control
India: Drugs Controller General of India
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ukraine: Ministry of Health
Bulgaria: Bulgarian Drug Agency

Keywords provided by Novartis:
Treatment
associated
with CRI

Additional relevant MeSH terms:
Anemia
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014