Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD)
- Conditions
- AnemiaChronic Kidney Disease
- Interventions
- Registration Number
- NCT02044653
- Lead Sponsor
- Genexine, Inc.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 257
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group E (Part A) GX-E2 GX-E2 : Subcutaneously injection every 4 weeks (Q4W) at dose 5ug/kg Group B (Part A) GX-E2 GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 5ug/kg Group F (Part A) GX-E2 GX-E2 : Subcutaneously injection every 4 weeks (Q4W) at dose 8ug/kg Group J (Part B) GX-E2 GX-E2 : Intravenously injection every week (Q1W) at dose 5ug/kg Group A (Part A) GX-E2 GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 3ug/kg Group D (Part A) GX-E2 GX-E2 : Subcutaneously injection every 4 weeks (Q4W) at dose 3ug/kg Group L (Part B) GX-E2 GX-E2 : Intravenously injection every 2 weeks (Q2W) at dose 8ug/kg Group C (Part A) GX-E2 GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 8ug/kg Group H (Part B) GX-E2 GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 8ug/kg Group I (Part B) MIRCERA MIRCERA : Subcutaneously injection every 2 weeks (Q2W) at dose 0.6ug/kg Group K (Part B) GX-E2 GX-E2 : Intravenously injection every week (Q1W) at dose 8ug/kg Group G (Part B) GX-E2 GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 5ug/kg Group M (Part B) NESP NESP : Intravenously injection every week (Q1W) at dose 30ug
- Primary Outcome Measures
Name Time Method average change of Hemoglobin level 6 weeks (Part A) & 14 weeks (Part B) change from baseline in Hemoglobin level
- Secondary Outcome Measures
Name Time Method 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
change of red blood cell indices 6 weeks (Part A) & 14 weeks (Part B) change from baseline in red blood cell indices
immunogenicity: ratio of neutralizing antibody & binding antibody in subjects 6 weeks (Part A) & 14 weeks (Part B) comparison from pre-treatment to post-treatment
incidence, frequency, amount of blood transfusion 6 weeks (Part A) & 14 weeks (Part B) Incidence of adverse events
Trial Locations
- Locations (5)
Bundang Seoul National University College of Medicine
🇰🇷Gumi, Korea, Republic of
Gangnam severance hospital
🇰🇷Seoul, Korea, Republic of
Bucheon St. Mary's Hospital
🇰🇷Bucheon, Korea, Republic of
The Catholic University of Korea Incheon St.Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Seoul St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of