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

• Status: Terminated
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandoz
• Treatments: Epoetin Alfa

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.