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Clinical Trials List

Protocol NumberP304-EPO

2016-03-15 - 2018-03-15

Phase III

Recruiting10

Terminated8

ICD-10D63.1

Anemia in chronic kidney disease

ICD-9285.21

Anemia in end-stage renal disease

A Phase III Trial to Compare the Safety and Efficacy of Intravenous UB-851 and Eprex® With an Extension Safety Evaluation in Subjects With Renal Anemia on Hemodialysis

Trial Applicant
Sponsor

UBI Pharma Inc.
Trial scale

Taiwan Multiple Center
Update

2025/08/20

Investigators and Locations

Principal Investigator Der-Cherng Tarng Division of Nephrology

Taipei Veterans General Hospital

Taiwan National PI

唐德成

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

4 Recruiting

Audit

None

Principal Investigator 王憲奕 Division of Nephrology

Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王偉傑 Division of Nephrology

Tao-Yuan General Hospital Minisity of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 蕭志忠 Division of Nephrology

Camillian Saint Mary's Hospital Ludong

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蔡信宏 Division of Nephrology

Cheng Hsin General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 黃國清 Division of Nephrology

Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 張浤榮 Division of Nephrology

Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 方華章 Division of Nephrology

Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林建宇 Division of Nephrology

En Chu Kong Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王家良 Division of Nephrology

Kuang Tien General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Ya-Chung Tian Division of Nephrology

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Hsing Wu Division of Nephrology

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 李進昌 Division of Nephrology

Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Hung Huang Division of Nephrology

Taoyuan Chang Gung Memorial Hospital of The C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator

Show-Chwan Memorial Hospital

Co-Principal Investigator

黃忠餘 Division of Nephrology
田志宏 Division of Nephrology

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 徐邦治 Division of Nephrology

Hualien Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳思嘉 Division of Nephrology

Kaohsiung Municipal Siaogang Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Yi wen chiu Division of Nephrology

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Renal Anemia

Objectives

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.

Test Drug

UB-851

Active Ingredient

Epoetin

Dosage Form

Dosage

10,000

Endpoints

Primary Outcome Measures :
Mean change in hemoglobin (Hb) levels [ Time Frame: Baseline and the evaluation period (evaluation period: Week21-Week24) ]
Mean change in weekly epoetin dosage. between baseline and the evaluation period [ Time Frame: Baseline and the evaluation period (evaluation period: Week21-Week24) ]
Adverse events (AEs): incidence and severity of all drug-related AEs [ Time Frame: up to 52 weeks ]
Immunogenicity: occurrence of anti-erythropoietin antibody [ Time Frame: up to 52 weeks ]

Inclution Criteria

Main Inclusion Criteria:

1. Subjects signed informed consent before undergoing any study procedures.
2. Subjects aged 20 to 85 years.
3. 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.

Exclusion Criteria

Main Exclusion Criteria:

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

The Estimated Number of Participants

Taiwan

195 participants
Global

0 participants