Prospective, Randomized, Single-blind, Active-controlled (Part B), Multi-center Phase II Clinical Trial to Explore the Fixed Starting Dose and Treatment Schedule and to Evaluate the Safety of GX-E2 Administered Intravenously/Subcutaneously in the Anemic Patients Diagnosed with Chronic Kidney Disease Receiving Hemodialysis (HD)/Peritoneal dialysis (PD)
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0001614
- Lead Sponsor
- Genexine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 252
•Written informed consent
•=18 yr of age
•Chronic Kidney diseases with hemodialysis, peritoneal dialysis
•Adequate Kt/V(hemodialysis=1.2, peritoneal dialysis=1.7), serum ferritin (=100g/dl)
•No erythropoietin (EPO) therapy within 2month before the planned first dose of GX-E2 and Hb<10g>/dL or No EPO therapy within month before the planned first dose of GX-E2 and Hb<10g>/dL
•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
1) Refractory patient to the known erythropoiesis-stimulating agents (ESA) treatment
2) Patient who received transfusion in the last 3 months.
3) Patient who administered other prohibited drug and regulated period is not yet progressed
4) Patient who donated or lost blood for more than 400 ml in last 2 months
5) Patient with hypersensitivity, shock, or past history to the investigational drug, contents of investigational drug, or similar ESA drugs
6) Acute or chronic organ seizure disorder (asthma, COPD, etc.) determined by the investigator, which may be clinically deteriorated by the drug administration
7) With active infection or had infection that required IV antibiotic in the last 4 weeks based on the first administration day
8) Grand Mal epilepsy
9) Had major surgery in last 3 months (excluding access surgery)
10) Patient with malignant tumor occurred in last 5 years (However, it is accepted if it is excised as a skin cancer and not a melanoma.)
11) Ischemic stroke occurred in last 3 years
12) 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
13) Patient with uncontrolled hypertension
14) Congestive heart failure>NYHA functional class III; unstable coronary artery disease; myocardial infarction occurred in last 3 months
15) Uncontrolled arrhythmia
16) Patient with high risk of thrombosis and embolism
17) Systemic blood disease (e.g. Pure Red Cell Anemia, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia)
18) Below absolute neutrophil count 1,500/uL within screening periods
19) Platelet level is less than 50 × 109/L within screening periods
20) Untreated hyperparathyroidism determined by the investigator that they cannot participate in the study
21) Untreated hypothyroidism determined by the investigator that they cannot participate in the study
22) The cause of the splenomegaly is anemia or severe splenomegaly (based on long axis>20 cm)
23) Blood alanine aminotransferase (ALT) exceeds 3xUNL
24) Blood aspartate aminotransferase (AST) exceeds 3xUNL
25) Blood total bilirubin exceeds 1.5X UNL
26) Blood albumin is less than 3g/dl
27) Past history of alcohol and other drug abuse in last 6 months prior to screening
28) Experience of dependent administration of psychotropic drugs and narcotic analgesics (exclude sleeping pills caused by insomnia)
29) Mental disorder or other CNS disorder determined that the study evaluation cannot be conducted
30) Unable to communicate (exclude illiterate or who is not able to understand questionnaire and question of patient diary)
31) Subject with insufficient awareness of study and uncooperative who is determined unable to participate until the end of study (one with no intention to give effort to perform each evaluation visit and extend previously planned elective surgery)
32) Breast feeding female who does not want to cease pregnancy or breast feeding
33) Female of childbearing age who does not give pledge to the effective contraception (Effective contraceptive method: sterilization, contraceptive, intrauterine device, condom, and barrier methods using spermicide)
34) Subject who is currently participating in a clinical trial or did not reached 30 days from the previous clinical trial
35) Patient with other medical condition in which the safety may be threatened by administering investigational drug and in which the i
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method average change of Hemoglobin level
- Secondary Outcome Measures
Name Time Method change of Hemoglobin level from baseline to follow up period;change of reticulocyte indices;change of red blood cell indices ;incidence, frequency, amount of blood transfusion;incidence, degree, outcome of adverse event ;immunogenicity: ratio of neutralizing antibody & binding antibody in subjects ;Maximum hemoglobin (Hb) changes and elapsed time to reach compare to the baseline after administration of investigational drug;Percentage of subjects who had increased hemoglobin (Hb) level monthly average changes of each for less than 1.0g/dl, 1.0-2.0g/dl, more than 2.0g/dl;Treatment compliance during administration period of investigational drug;(Part B only) AUECHb 13-14 weeks during evaluation period after administration of investigational drug;(Part B only) Evaluation of target response rate after IV/SC administration of the investigational drug (GX-E2) during anemia treatment period of subjects with chronic kidney disease receiving hemodialysis/peritoneal dialysis