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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,695
HX575 epoetin alfa i.v. will be administered according to the SmPC
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
Time frame: 6 months
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