Subjects with chronic kidney disease (CKD) previously enrolled in other efficacy and/or safety studies with HX575, after these subjects have participated in the earlier study. MedDRA version: 9.1 Level: LLT Classification code 10009120 Term: Chronic renal failure anaemia
Conditions
Interventions
Trade Name: Binocrit®
Product Name: HX575 recombinant human erythropoietin (registered as Binocrit®)
Product Code: HX575
Pharmaceutical Form: Solution for injection
Sponsors
Hexal Biotech ForschungsGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must give written informed consent before any assessment is performed. Consent to participate in one of the three previous studies (see below) is not sufficient. 2. Male and female subjects having participated in one of the following studies: • Post-authorization safety study to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among CKD subjects receiving HX575 recombinant human erythropoietin alfa i.v. (Protocol number: 2006-66-INJ-14, EUDRACT number: 2007-005728-34) • 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 subjects (Protocol number: 2007-22-INJ-17 (HX02), EUDRACT number: 2007-001906-26) • An open label, single-arm, baseline-controlled, multicenter study to evaluate the efficacy, safety and immunogenicity of subcutaneous HX575 administered once a week (qw) and once every two weeks (q2w) in the treatment of anemia associated with chronic kidney disease in predialysis and dialysis subjects (Protocol number: HX575-304, EUDRACT number: 2008-002696-27) Treatment with any ESA other than the study drug is not permitted between the subject’s end of the previous study and enrollment into HX575-305. Thus the baseline visit of the HX575-305 study must be combined with the final visit of the previous study. 3. Subjects with controlled symptomatic anemia under s.c. or i.v. maintenance therapy with HX575 or a comparator in one of the above studies 4. HX575 is not commercially available for the subject’s specific indication or mode of application in the subject’s country 5. Continued ability to follow study instructions and high probability to appear to study visits 6. Compliant with s.c. self administration in previous study (if applicable) 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: 1. Subjects no longer requiring ESA therapy 2. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 3. Uncontrolled hypertension, defined as systolic blood pressure of > 160 mmHg and diastolic blood pressure measurement > 100 mmHg (average of two values with at least one day between measurements) 4. Known primary lack of efficacy (LOE), unexplained loss of effect to a recombinant erythropoietin product 5. History of PRCA or aplastic anemia 6. History of anti-erythropoietin antibodies 7. Cannot receive adequate antithrombotic prophylaxis for any reason 8. Pregnant women or nursing mothers 9. Women of childbearing potential who do not agree to maintain effective birth control during the study treatment period 10. Hypersensitivity to the active substance or to any of the excipients 11. Subjects with any form of psychiatric disorder which may invalidate communication 12. Previous participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long term safety of HX575 (recombinant human erythropoietin alfa)in subjects receiving stable doses of HX575 s.c. or i.v. The purpose of the current study is twofold: (1) To enlarge the long term safety database by providing safety data on the s.c. and on the i.v. administration of HX575 over an additional treatment period of up to three years (2) To bridge the time gap between the end of previous trials and commercial availability of HX575 in the patient specific country and indication;Secondary Objective: • To evaluate the local tolerability of HX575 at the injection site • To evaluate clinically relevant changes in laboratory parameters under therapy with HX575 • To evaluate clinically relevant changes in vital signs, in particular blood pressure under therapy with HX575 Exploratory objectives • To compare the incidence, frequency, extent, and/or severity of endpoints between subject groups receiving HX575 via the i.v. or the s.c. route • To assess the efficacy of HX575;Primary end point(s): • Primary endpoints o Incidence and severity of all AEs and all drug related AEs (i.e. Adverse drug reactions ADRs) • Secondary endpoints o Local tolerability at the injection site o Clinically relevant changes in laboratory parameters | — |
Countries
Belgium, France, Germany, Slovakia, Spain
Outcome results
None listed