An open label, multinational, multicenter study to evaluate the safety of HX575 recombinant human erythropoietin alfaEstudio abierto, multicéntrico y multinacional para evaluar la seguridad de la eritropoyetina humana recombinante alfa HX575

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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