Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of HX575 Epoetin Alfa in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Patients (SENSE)

NCT01576341 Phase 3 COMPLETED Results posted

The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)

Details

Lead sponsor	Sandoz
Phase	Phase 3
Status	COMPLETED
Enrolment	417
Start date	2012-04
Completion	2015-06

Conditions

• Chronic Kidney Disease

Interventions

• HX575 epoetin alfa (Sandoz)

Primary outcomes

• Anti-Erythropoietin (EPO) Antibodies — 52 weeks
  The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay

Countries

Germany, Italy, Poland, Romania, Russia, Turkey (Türkiye), Ukraine