Status:
COMPLETED
The Clinical Study for Evaluating The Safety And Efficacy Of Epodion®
Lead Sponsor:
PT. Daewoong Infion
Collaborating Sponsors:
Equilab International
Conditions:
Chronic Kidney Disease (CKD)
Eligibility:
All Genders
18-74 years
Phase:
NA
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 produ...
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), titratio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2022
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT05373303
Start Date
November 7 2019
End Date
January 28 2022
Last Update
July 14 2022
Active Locations (1)
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1
Gatot Soebroto Army Hospital
Jakarta, Indonesia, 10410