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

Chronic Kidney Disease Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00632125
Study type Interventional
Source Sandoz
Contact
Status Completed
Phase Phase 4
Start date July 2008
Completion date September 2010
View Details
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