Study to Compare the Safety and Efficacy of UB-851 and Eprex®

UBI Pharma

Status and phase

Completed

Phase 3

Conditions

Renal Anemia

Treatments

Biological: UB-851

Biological: Eprex

Study type

Interventional

Funder types

Industry

Identifiers

NCT02708914

P304-EPO

Details and patient eligibility

About

The primary objective of this study is to evaluate a 1:1 dose conversion from Eprex® to UB-851 in terms of clinical efficacy and safety in subjects with chronic renal failure receiving hemodialysis.

Full description

This is a 52-week, phase III trial consisting of two parts:

Part I is designed as a double-blind, randomized, multicenter, parallel-group study to evaluate the efficacy and safety of UB-851 in comparison to Eprex® in subjects with renal anemia on hemodialysis with a treatment period of 24 weeks.

Part II is designed as a single-arm, safety evaluation period (from week 25 to week 52) to evaluate the long-term safety and immunogenicity of UB-851.

Enrollment

269 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

Subjects signed informed consent before undergoing any study procedures.
Subjects aged 20 to 85 years.
Hemodialysis subjects with chronic renal failure and renal anemia in outpatient clinic currently on stable Eprex® treatment administered by intravenous injection (1 to 3 times per week) for at least 3 months prior to randomization.

Main Exclusion Criteria:

Maintenance epoetin dose > 300 IU/kg per week.
Treatment with long-acting epoetin analogues.
Detectable anti-erythropoietin antibodies with clinical symptoms at screening visit, or history of Pure Red Cell Aplasia (PRCA).