Anemia, Chronic Kidney Disease
Conditions
Keywords
Phase 2
Brief summary
The primary objective of study is * Part A : To explore the optimal fixed starting dose and dosing interval of GX-E2 * Part B : To evaluate the proof of concept (POC) of GX-E2
Detailed description
The secondary objective of study is to evaluate: * change of red blood cell indices in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously * change of reticulocyte indices in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously * safety of GX-E2 when administering intravenously/subcutaneously * incidence of blood transfusion in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously * Immunogenicity in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously
Interventions
Sponsors
Genexine, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent * ≥18 yr of age * Chronic Kidney diseases with hemodialysis, peritoneal dialysis with Kt/V ≥ 1.2 (hemodialysis) or Kt/V ≥ 1.7 (peritoneal dialysis) within a year * Adequate transferrin saturation (≥20%), serum ferritin (≥100ug/L) * Should have received Vitamine B12 ≥ 3 months before the first dose of study agent * Should have received Folate ≥3 months before the first dose of study agent * No erythropoietin (EPO) therapy within 2 months before the planned first dose of GX-E2 and Hb\<10g/dL or No EPO therapy within a month (peritoneal dialysis) or 2 weeks (hemodialysis) before the planned first dose of GX-E2 and Hb\<10g/dL.
Exclusion criteria
* Refractory to erythropoiesis stimulating agent (ESA) treatment * History of blood transfusion within 3 months * Donation or loss of blood for more than 400 milliliters (mL) within 8 weeks * History of a known or suspected hypersensitivity, shock, or past history to the investigational drug or to similar ESA drugs * Acute or chronic organ seizure disorder (including asthma and chronic obstructive pulmonary disease) which may be clinically deteriorated by the drug administration * Active infection or history of infection that required intravenous injection of antibiotics in the last two months * Grand Mal epilepsy * Major surgery within 3 months other than access surgery * Malignant tumor within 5 years other than successfully treated skin cancer that is not melanoma * Ischemic stroke within 3 years * Chest x-ray findings determined that they cannot participate in the study for clinically abnormal findings by the baseline chest x-ray findings or previously taken chest x-ray findings * Uncontrolled hypertension * Congestive heart failure more severe than NYHA functional class III; unstable Coronary artery disease (CAD); myocardial infraction within 3 months * Uncontrolled arrhythmia * High risk of thrombosis and embolism * Systemic blood diseases (e.g. Pure red cell anemia, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia) * Absolute neutrophil count below 1,500 per microliter (uL) within screening periods * Platelet count less than 5e10 per liter (L) within screening periods * Hyperparathyrodism / hypothyrodism * Splenomegaly caused by anemia or severe splenomegaly (\>20cm) * Blood aspartate aminotransferase/alanine aminotransferase (ALT/AST) concentration exceeds three times Upper Normal Limit of Normal (UNL) * Blood total bilirubin concentration exceeds 1.5 times Upper Normal Limit of Normal (UNL) * Blood albumin concentration below 3g per deciliter (dl) * History of drug or alcohol abuse in the 6 months prior to the screening * History of psychotropic or narcotic analgesic drugs dependence within 6 months prior to the screening * Mental disorder or other central nervous system disorder determined that the study evaluation cannot be conducted * Lack of understanding of the study and cooperation (one with no intention to give efforts to perform each evaluation visit and extend previously planned elective surgery) * Female subjects with childbearing potential who are pregnant, breastfeeding or intends to become pregnant * Participation in any drug study within 30 days prior to dosing * Any other ineligible condition at the direction of the investigator that would be ineligible to participate the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| average change of Hemoglobin level | 6 weeks (Part A) & 14 weeks (Part B) | change from baseline in Hemoglobin level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of red blood cell indices | 6 weeks (Part A) & 14 weeks (Part B) | change from baseline in red blood cell indices |
| change of reticulocyte indices | 6 weeks (Part A) & 14 weeks (Part B) | change from baseline in reticulocyte indices |
| incidence, degree, outcome of adverse event | 6 weeks (Part A) & 14 weeks (Part B) | Incidence of adverse events |
| incidence, frequency, amount of blood transfusion | 6 weeks (Part A) & 14 weeks (Part B) | Incidence of adverse events |
| immunogenicity: ratio of neutralizing antibody & binding antibody in subjects | 6 weeks (Part A) & 14 weeks (Part B) | comparison from pre-treatment to post-treatment |
Countries
South Korea
Outcome results
None listed