NCT00632125

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

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,695 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	HX575 recombinant human erythropoietin alfa	HX575 epoetin alfa i.v. will be administered according to the SmPC

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-03-01
• Completion: 2010-09-01
• First posted: 2008-03-10
• Last updated: 2017-07-11
• Results posted: 2017-07-11

Locations

114 sites across 10 countries: Austria, Bulgaria, France, Germany, Italy, North Macedonia, Poland, Romania, Russia, Ukraine