anemia associated with chronic renal insufficiency in predialysis patients MedDRA version: 9.1 Level: LLT Classification code 10058116 Term: Nephrogenic anaemia
Conditions
Interventions
Trade Name: Epoetin alfa HEXAL
Product Name: Epoetin alfa HEXAL
Product Code: HX575
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Epoetin alfa HEXAL
Current Sponsor code: HX575
Othe
Sponsors
HEXAL AG
Eligibility
Sex/Gender
All
Inclusion 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 years 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 7.50 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. Follow-up Phase: - Previously randomized to the treatment period of this study and received at least one administration of study medication. - Written informed consent of patient for safety follow-up period Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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 (eg 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immunogenicity of EPO HEXAL vs. ERYPO administered subcutaneously in the treatment of anemia associated with chronic renal insufficiency not severe enough to require dialysis;Secondary Objective: To assess the safety of EPO HEXAL vs. ERYPO administered subcutaneously in the treatment of anemia associated with chronic renal insufficiency not severe enough to require dialysis;Primary end point(s): Primary Efficacy Variables: Not applicable Secondary Efficacy Variables: Mean absolute change in hemoglobin after 5 weeks of treatment Hemoglobin response after weeks 5 and 9 of treatment Time required to achieve first hemoglobin response Epoetin dose at the time of hemoglobin response Hemoglobin concentrations over time / by visit: This endpoint is based on the Hb measurements on every visit (every other, every second or every fourth week). Weekly change in hemoglobin from baseline Epoetin dose over time / by visit: Any change in the epoetin dosage should be documented in the CRF with respect to dosage, application scheme and reason why the dose adjustment was necessary. Number of patients receiving red blood cell transfusions: Red blood cell transfusions are only indicated in severely anemic patients with recognized symptoms or signs of anemia, e.g. a patient with acute blood loss associated with hemodynamic instability or a patient with severe angina pectoris. If there is the need of a red blood cell transfusion the total amount of blood given and the reason for this medical intervention has to be documented in the CRF. Overall efficacy as judged by the investigator | — |
Countries
Austria, Bulgaria, France, Germany
Outcome results
None listed