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

Primary Purpose

Chronic Kidney Disease (CKD)

Status

Completed

Phase

Not Applicable

Locations

Indonesia

Study Type

Interventional

Intervention

Recombinant Human Erythropoietin Alpha

About this trial

This is an interventional treatment trial for Chronic Kidney Disease (CKD)

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients who are at least 18 years old and younger than 75 years of age at the time of screening visit.
Patients with End-Stage Renal Failure (ESRD) who are chronically receiving hemodialysis and have anemia.
Patients with a mean baseline Hb concentration within Hb level ≥ 9 g/dL during the screening period.
Haemodialysis patients with anemia associated with Chronic Kidney Disease (CKD) currently receiving stable maintenance therapy with Epoetin alfa at least once per week
Adequate iron substitution status (serum ferritin ≥ 100 μg /dl or saturated transferrin levels ≥ 20%).
Patients who understand the information provided to them or their representatives and may provide written consent.

Exclusion Criteria:

Contraindication with Epoetin therapy.
Documented active bleeding in the last 12 weeks prior to screening period.
Any blood transfusion within the last 2 weeks prior Screening period.
History of malignancy of any organ system within the last 5 years.
Patients with uncontrolled hypertension (in case the mean value of diastolic blood pressure as measured 4 times during the baseline observation period is 110 mmHg or more).
Patients hyporesponsive epoetin treatment or had medical history of experiencing pure red blood cell forming failure after being administered with Epoetin products.
Known bone marrow fibrosis (osteitis fibrosa cystica).
Patient with serious cardiovascular disorders: myocardial infarction, patients with congestive heart failure (NYHA class Ⅲ or higher), ischemic vascular disease
Patient received percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG) during the last 6 months prior to screening.
Patient with the following liver disorder: Patient diagnosed with liver cirrhosis, hepatitis B, or on active treatment hepatitis C, and patients with ALT or AST exceeding the upper limits of the normal level by more than double.
Patients whose kidney transplant is expected or already planned for survival.
Secondary anemia to other causes different to the CKD (aplastic anemia, hemolytic anemia, sickle cell anemia, multiple myeloma, leukemia, myelodysplastic syndrome).
Patients with the following diseases and who are considered unfit to enroll in the clinical study: mental system disease, mental disease, drug intoxication, epilepsy, lung infarction, cerebral infarction, positive HIV antibody, systemic lupus erythematosus, immunosuppressive condition and general infection
Pregnancy or lactation period in female patients, or women of childbearing potential without an effective method of birth control.
Patients who were considered unfit for study by the principal investigators or by the co-investigator.

Sites / Locations

Gatot Soebroto Army Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Drug

Reference Drug

Arm Description

Recombinant Human Erythropoietin Alfa, dosage : 50 IU/Kg body weight three times per week, and continued to titrated dose closely to achieve baseline Hb level 10-12g/dL

Outcomes

Primary Outcome Measures

Hb level change

Hb level change between Test and Reference Drug

Secondary Outcome Measures

mean change in weekly dosage per kg body weight

Dosage for Mean change in mg/Kg Body Weight

Full Information

NCT ID

NCT05373303

First Posted

April 26, 2022

Last Updated

July 12, 2022

Sponsor

PT. Daewoong Infion

Collaborators

Equilab International

1. Study Identification

Unique Protocol Identification Number

NCT05373303

Brief Title

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

Official Title

The Clinical Study for Evaluating The Safety And Efficacy Of Epodion® During Maintenance Period Until Evaluation Period On CKD (Chronic Kidney Disease) Patients: An Open Label, Randomized, Active Drug-Comparative, Parallel-Designed, Multi-Center Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

November 7, 2019 (Actual)

Primary Completion Date

May 15, 2021 (Actual)

Study Completion Date

January 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PT. Daewoong Infion

Collaborators

Equilab International

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

This was an open-label, randomized, active drug-comparative, parallel-designed, multi-center study in hemodialysis patients with anemia. 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. The primary endpoints of efficacy evaluation were to demonstrate that treatment of test product was equivalence with the reference product by evaluating Hb level change between baseline (Week 5-8/9-12) and evaluation period (Week 33-36/37-40), while the secondary endpoints were to obtain data mean change in weekly dosage per kg body weight between the baseline period and the evaluation period, to calculate instability rate of Hb level during maintenance and evaluation period as defined when Hb level dropped below 8 g/dL or increased by more than 13 g/dL and to evaluate the Hb and hematocrit (Ht) level during maintenance and evaluation period. The safety evaluation was conducted based on the incidence of the adverse events of both local and systemic reactions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease (CKD)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

open-label, randomized, active drug-comparative, parallel-designed

Masking

None (Open Label)

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test Drug

Arm Type

Experimental

Arm Description

Recombinant Human Erythropoietin Alfa, dosage : 50 IU/Kg body weight three times per week, and continued to titrated dose closely to achieve baseline Hb level 10-12g/dL

Arm Title

Reference Drug

Arm Type

Active Comparator

Arm Description

Recombinant Human Erythropoietin Alfa, dosage : 50 IU/Kg body weight three times per week, and continued to titrated dose closely to achieve baseline Hb level 10-12g/dL

Intervention Type

Biological

Intervention Name(s)

Recombinant Human Erythropoietin Alpha

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Recombinant Human Erythropoietin Alpha

Intervention Description

Primary Outcome Measure Information:

Title

Hb level change

Description

Hb level change between Test and Reference Drug

Time Frame

baseline (Week 5-8/9-12) and evaluation period (Week 33-36/37-40).

Secondary Outcome Measure Information:

Title

mean change in weekly dosage per kg body weight

Description

Dosage for Mean change in mg/Kg Body Weight

Time Frame

baseline (Week 5-8/9-12) and evaluation period (Week 33-36/37-40).

Other Pre-specified Outcome Measures:

Title

instability rate of Hb (hemoglobin)

Description

instability rate of Hb in Percent (%)

Time Frame

maintenance (week 10-14/32-36) and evaluation period (Week 33-36/37-40)

Title

Hb (hemoglobin) and hematocrit level

Description

Hb (hemoglobin) in gram/desiLiter and hematocrit level in Percent (%)

Time Frame

maintenance (week 10-14/32-36) and evaluation period (Week 33-36/37-40)

Title

incidence of adverse event

Description

incidence of adverse event between Test and Reference Drug

Time Frame

during the study evaluation from baseline (Week 5-8/9-12) to evaluation period (Week 33-36/37-40)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients who are at least 18 years old and younger than 75 years of age at the time of screening visit. Patients with End-Stage Renal Failure (ESRD) who are chronically receiving hemodialysis and have anemia. Patients with a mean baseline Hb concentration within Hb level ≥ 9 g/dL during the screening period. Haemodialysis patients with anemia associated with Chronic Kidney Disease (CKD) currently receiving stable maintenance therapy with Epoetin alfa at least once per week Adequate iron substitution status (serum ferritin ≥ 100 μg /dl or saturated transferrin levels ≥ 20%). Patients who understand the information provided to them or their representatives and may provide written consent. Exclusion Criteria: Contraindication with Epoetin therapy. Documented active bleeding in the last 12 weeks prior to screening period. Any blood transfusion within the last 2 weeks prior Screening period. History of malignancy of any organ system within the last 5 years. Patients with uncontrolled hypertension (in case the mean value of diastolic blood pressure as measured 4 times during the baseline observation period is 110 mmHg or more). Patients hyporesponsive epoetin treatment or had medical history of experiencing pure red blood cell forming failure after being administered with Epoetin products. Known bone marrow fibrosis (osteitis fibrosa cystica). Patient with serious cardiovascular disorders: myocardial infarction, patients with congestive heart failure (NYHA class Ⅲ or higher), ischemic vascular disease Patient received percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG) during the last 6 months prior to screening. Patient with the following liver disorder: Patient diagnosed with liver cirrhosis, hepatitis B, or on active treatment hepatitis C, and patients with ALT or AST exceeding the upper limits of the normal level by more than double. Patients whose kidney transplant is expected or already planned for survival. Secondary anemia to other causes different to the CKD (aplastic anemia, hemolytic anemia, sickle cell anemia, multiple myeloma, leukemia, myelodysplastic syndrome). Patients with the following diseases and who are considered unfit to enroll in the clinical study: mental system disease, mental disease, drug intoxication, epilepsy, lung infarction, cerebral infarction, positive HIV antibody, systemic lupus erythematosus, immunosuppressive condition and general infection Pregnancy or lactation period in female patients, or women of childbearing potential without an effective method of birth control. Patients who were considered unfit for study by the principal investigators or by the co-investigator.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonny Jonny, MD

Organizational Affiliation

Gatot Soebroto Army Hospital, Jakarta

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gatot Soebroto Army Hospital

City

Jakarta

ZIP/Postal Code

10410

Country

Indonesia

12. IPD Sharing Statement

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

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