anemia associated with chronic kidney disease in pre-dialysis and dialysis patients MedDRA version: 17.0 Level: LLT Classification code 10058124 Term: Nephrogenic anemia System Organ Class: 100000004851
Conditions
Interventions
Trade Name: Binocrit
Product Name: HX575 epoetin alfa
Product Code: HX575
Pharmaceutical Form: Solution for injection
INN or Proposed INN: EPOETIN ALFA
CAS Number: 113427-24-0
Current Sponsor code: HX
Sponsors
Hexal AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adult patients with CKD induced anemia, with or without dialysis treatment, requiring ESA therapy • Patients with anemia, defined as mean Hb level less than or equal to 11.0 g/dL, for patients naïve to ESA therapy or between 9.0 g/dL and 12.0 g/dL for patients receiving ESA therapy, based on at least 2 Hb measurements during the 4-week screening period • Patients who are not naïve to ESA therapy should be receiving stable i.v. or s.c. maintenance therapy with an European Union (EU)-approved ESA (stable defined as = 30% change in weekly dose during screening) corresponding to a maximum weekly dose of 300 IU/kg or equivalent, and in accordance with the relevant prescribing information • Adequate iron substitution status defined as serum ferritin =200 µg/L and =800 µg/L for patients on dialysis and serum ferritin = 100 µg/L and = 800 µg/L for patients not on dialysis, and transferrin saturation = 20% and =50% (confirmed by a sample taken at the first screening visit). 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 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: • History of Pure Red Cell Aplasia (PRCA) or anti-erythropoietin (EPO) antibodies • Contraindications for ESA therapy • Active gastrointestinal bleeding during the screening period • Evidence of decompensated cirrhosis • Serum albumin < 3.0 g/dL • Immunocompromized patients (immunosuppressive treatment, chemotherapy) • Hepatitis C infection on an active treatment or hepatitis B or human immunodeficiency virus (HIV) infection • Systemic lupus erythematosus • Symptomatic congestive heart failure (New York Heart Association (NYHA) class III and IV) • Unstable angina pectoris, or myocardial infarction within 6 months prior to Visit 1 • Percutaneous coronary intervention, or coronary artery bypass grafting during the last 6 months prior to Visit 1 • History of malignancy of any organ system • History of thrombosis (excluding vascular access thrombosis) or pulmonary embolism • History of use of any non-EU approved ESA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the lack of immunogenicity of HX575 administered s.c. in the treatment of anemia associated with CKD;Secondary Objective: To assess the safety of HX575 administered s.c. and to demonstrate that administration at least once per week adequately corrects or maintains the correction of anemia associated with CKD;Primary end point(s): The incidence of antibody formation against epoetin ;Timepoint(s) of evaluation of this end point: at visits -2, 1, 3 and at visits 5 to 16 and follow-up visits | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints • Hemoglobin (Hb) levels over time and change from baseline • Weekly epoetin dosage (IU and IU/kg) over time and change from baseline • Percentage of patients with Hb values within the target range of 10.0 -12.0 g/dL per visit and during the whole study • Frequency of patients receiving red blood cell (RBC)/whole blood transfusions Secondary safety endpoints • Incidence and severity of adverse events (AEs), and of drug related AEs • Incidence of thromboembolic events • Incidence of malignancies ;Timepoint(s) of evaluation of this end point: • Hemoglobin (Hb) levels over time and change from baseline: at all visits • Weekly epoetin dosage (IU and IU/kg) over time and change from baseline: weekly • Percentage of patients with Hb values within the target range of 10.0 -12.0 g/dL per visit and during the whole study : at all visits • Frequency of patients receiving red blood cell (RBC)/whole blood transfusions: throughout the study • Incidence and severity of adverse events (AEs), and of drug related AEs: throughout the study • Incidence of thromboembolic events: throughout the study • Incidence of malignancies: throughout the study | — |
Countries
European Union, Germany, Poland, Russian Federation, Turkey, Ukraine
Contacts
Public ContactMarité Ode, Scientific Expert HX575
Hexal AG
Outcome results
None listed