MedTrace Logo

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

NCT05373303 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2022-07-14

No results posted yet for this study

Summary

The study was conducted to evaluate whether the efficacy and safety profile of recombinant human erythropoietin (rhEPO) manufactured by Daewoong Pharmaceutical Co., Ltd was similar to biological products approved by the drug safety regulatory authority.

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

Sponsors & Collaborators

  • Equilab International

    collaborator UNKNOWN

  • PT. Daewoong Infion

    lead INDUSTRY

Principal Investigators

  • Jonny Jonny, MD · Gatot Soebroto Army Hospital, Jakarta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-07
Primary Completion
2021-05-15
Completion
2022-01-28

Countries

  • Indonesia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05373303 on ClinicalTrials.gov