Status:
TERMINATED
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
Lead Sponsor:
Sandoz
Conditions:
Anemia
Chronic Renal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
337 Patients enrolled
Trial Details
Trial ID
NCT00701714
Start Date
September 1 2007
End Date
January 1 2010
Last Update
February 5 2018
Active Locations (123)
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1
Diakonissen KH Salzburg
Salzburg, Austria, 5020
2
LKH Steyr
Steyr, Austria, 4400
3
Krankenanstalt der Stadt Wien
Vienna, Austria, 1030
4
AKH Wien
Vienna, Austria, 1090