Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.

Study Overview
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Brief Summary
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Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney Disease (CKD) subjects receiving HX575 epoetin alfa i.v.

Detailed Description
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This study was a multi-center, multinational, prospective, single-arm clinical study with a 6-month treatment period. The primary objective was to extend the safety database of patients with CKD who receive i.v. HX575 epoetin alfa treatment and to monitor the adverse event (AE) profile under post-approval conditions.

Official Title
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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.

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: HX575 recombinant human erythropoietin alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CKD subjects with or without dialysis treatment Age over 18 years Subjects requiring i.v. ESA treatment Subjects likely to remain on i.v. ESA treatment for 6 months Provision of informed consent - Exclusion Criteria: Systemic immunosuppressive medication or any other drugs known to adversely affect the hemoglobin level Known primary lack of efficacy (LOE), unexplained loss of effect to a recombinant erythropoietin product History of PRCA or aplastic anemia History of anti-erythropoietin antibodies Uncontrolled hypertension Pregnant woman or nursing mother Women of childbearing potential do not agree to maintain effective birth control during the study treatment period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HX575 epoetin alfa i.v.<br>This post-authorization safety study was designed as a multi-center, multinational, prospective, single-arm clinical study with a 6-month HX575 (recombinant human) erythropoietin alfa treatment period. It was planned to include approximately 1,500 patients. | Drug: HX575 recombinant human erythropoietin alfa<br>* HX575 epoetin alfa i.v. will be administered according to the SmPC<br>* Other names: HX575 epoetin alfa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects | The incidence of relevant drug-related adverse events consisting of Epoetin alfa-induced immunogenicity and resulting blockade in erythroid maturation (e.g. pure red cell aplasia) and lack of efficacy | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD subjects with or without dialysis treatment