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

Sandoz

Status and phase

Terminated

Phase 3

Conditions

Anemia

Chronic Renal Insufficiency

Treatments

Drug: ERYPO

Drug: HX575 recombinant human erythropoietin alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT00701714

2007-22-INJ-17

Details and patient eligibility

About

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.

Enrollment

337 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.