The Clinical Study for Evaluating The Safety And Efficacy Of Epodion®

NACompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

November 7, 2019

Primary Completion Date

May 15, 2021

Study Completion Date

January 28, 2022

Conditions
Chronic Kidney Disease (CKD)
Interventions
BIOLOGICAL

Recombinant Human Erythropoietin Alpha

This study consisted of a screening period (4 weeks), titration period (4\~8 weeks) baseline evaluation period (4 weeks), maintenance period (24 weeks), and 4 weeks for the evaluation period. Patients who were eligible in the screening period underwent the titration period. The reference product at an individualized dose 3 times a week through intravenous injection was given and the hemoglobin (Hb) level of the subject was controlled to reach the target range of 10-12 g/dL in the titration period. In the maintenance period, the subjects were randomized and administered with reference product or test product that was done with the same doses regimen during the titration period through intravenous injection

BIOLOGICAL

Recombinant Human Erythropoietin Alpha

This study consisted of a screening period (4 weeks), titration period (4\~8 weeks) baseline evaluation period (4 weeks), maintenance period (24 weeks), and 4 weeks for the evaluation period. Patients who were eligible in the screening period underwent the titration period. The reference product at an individualized dose 3 times a week through intravenous injection was given and the hemoglobin (Hb) level of the subject was controlled to reach the target range of 10-12 g/dL in the titration period. In the maintenance period, the subjects were randomized and administered with reference product or test product that was done with the same doses regimen during the titration period through intravenous injection

Trial Locations (1)

10410

Gatot Soebroto Army Hospital, Jakarta

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Equilab International

UNKNOWN

lead

PT. Daewoong Infion

INDUSTRY