KCT0001614已完成未知
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)
Genexine0 个研究点目标入组 252 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 252
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
相似试验
进行中（未招募）
不适用
Clinical trials evaluating the effect of cranial electrotherapy stimulation (CES) for anxiety and stress reductioKCT0004065Hallym University Medical Center- Chuncheon60
尚未招募
不适用
Prospective, randomized, subject single-blind, double-arm study to evaluate the outcome of ADM without basement membrane in prosthetic breast reconstructioKCT0005852Asan Medical Center60
已完成
不适用
Randomized, ControlleD, Single Blinded, ProspEctive, MuLtIcenter Study EValuating Anatomic versus Targeted lead placement for Burst DR Therapy during the Trial Evaluation periodNL-OMON45537St. Jude Medical40
进行中（未招募）
不适用
Prospective, Randomized, Controlled, Double Blind Study on the Effectiveness of Movicol (PEG 3350) versus SedaStip (acacia fiber, psyllium fiber (Plantago ovata), fructose) in the Treatment of Chronic Functional Constipation in childhood. - NDMedDRA version: 12.1Level: LLTClassification code 10010774Term: ConstipationconstipationEUCTR2009-010945-30-ITIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II
进行中（未招募）
2 期
Clinical study to compare the immune response and safety of vaccine for prevention of Measles and Rubella diseases (MR vaccine) manufactured by Cadila Healthcare Ltd. with MR vaccine manufactured by Serum Institute of India Ltd. in children 9-12 months of ageCTRI/2017/05/008701Cadila Healthcare Ltd