Conditions: Chronic Kidney Disease
Keywords: CKD subjects with or without dialysis treatment
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1695
Healthy volunteers: no

Brief summary:
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:
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.

Arms:
arm 1: 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.

Interventions: intervention 1: HX575 recombinant human erythropoietin alfa
Intervention descriptions: intervention 1: HX575 epoetin alfa i.v. will be administered according to the SmPC

Protocol document: