NCT02839941Unknown不适用
An Open-label Study to Evaluate the Effect of Iguratimod Concomitant With Conventional Immunosuppressive Drugs on Preventing Antibody-induced Rejection in Human Leukocyte Antigen(HLA) Highly Mismatched Kidney Transplant Recipients
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Survival of transplanted kidney
研究概览
简要总结
The objective of the study is to evaluate the effect of iguratimod concomitant with conventional immunosuppressive drugs on preventing antibody-induced rejection in HLA Highly mismatched Kidney Transplant recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged ≥18, <65 years
- •At least 2 weeks post kidney transplantation from deceased or living donor
- •Stable renal graft function, i.e., serum creatinine undulation for 3 consecutive test <±10%
- •Serum creatinine<1.5×upper limits of normal(ULN)
- •Number of HLA mismatches ≥ 4
- •Panel Reactive Antibody(PRA) value pre-transplantation <10%
- •Concentration of conventional immunosuppressive drugs reach target ranges
- •Subjects are willing to participate in the study, fully informed, and sign informed consent form(ICF)
- •Women of childbearing potential (WOCBP) must have a negative pregnancy test within 24 hours prior to the start of study medication, and agree to use an acceptable method to avoid pregnancy for the entire study period and for up to 3 months after the last dose of study medication.
排除标准
- •Pregnant or nursing women
- •Currently clinical acute rejection;
- •Graft function hasn't recovered for delayed graft function (DGF), or primary non-function (PNF)
- •Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas)
- •Subjects with Liver failure
- •Abnormal hepatic, renal and hematopoietic function,
- •Alanine transaminase(ALT), Aspartate transaminase(AST)>1.5×ULN
- •White blood cell(WBC)<3.5×10^9/L
- •Hemoglobin(HGB)<80 g/L
- •Platelet count(PLT)<80×10^9/L.
- •Severe clinically relevant disease,
- •Abnormality in chest X ray image, such as Tuberculosis, Pulmonary interstitial fibrosis, or symptom or physical sign of clinical significance
- •Serious cardiovascular, hepatic, hematological, endocrinal disease, or malignancy 3）History of serious cardiovascular, hepatic, hematological, endocrinal disease, or malignancy
- •Immunodeficiency, uncontrolled active infection, and active gastrointestinal disease.
- •Women or men of childbearing potential plan to be pregnant recently;
- •Allergic with study drug, or excipient
- •Subject with psychiatric illness, which may put him/her into unacceptable risk in the opinion of investigators
- •Has received or is receiving Rituximab treatment
- •Iguratimod treatment within 1 week pre-transplantation, or during screening period
- •Received live vaccines in the previous 3 months, or plan to receive live vaccines during the study.
研究组 & 干预措施
experiment
Experimental
干预措施: Iguratimod (Drug)
experiment
Experimental
干预措施: Mycophenolate mofetil (Drug)
experiment
Experimental
干预措施: Tacrolimus (Drug)
experiment
Experimental
干预措施: Glucocorticoids (Drug)
Control
Sham Comparator
干预措施: Mycophenolate mofetil (Drug)
Control
Sham Comparator
干预措施: Tacrolimus (Drug)
Control
Sham Comparator
干预措施: Glucocorticoids (Drug)
结局指标
主要结局
Survival of transplanted kidney
时间窗: 52 week
Biopsy-proven acute rejection rates
时间窗: 0-52 week
次要结局
- Donor Specific Antibody(DSA) level compared to baseline(52 week)
- Adverse event(0-52 week)
- Graft renal function(52 week)
研究者
研究点 (1)
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