Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT05373303
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT05373303
Study Brief:
Protocol Section:
NCT05373303