A Multicenter, Randomized, Double-blind, Positive-control, Non-inferiority Clinical Trial on the Effectiveness and Safety of HCA-N Solution for the Preservation of Kidney Grafts During Kidney Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Percentage of subjects experiencing delayed graft function (DGF) post-transplantation.
研究概览
简要总结
To verify the effectiveness and safety of the HCA-N solution in actual clinical preservation, this study intends to conduct a prospective, randomized, and positive control clinical trial. Using the classic HTK solution as a reference, the study will focus on evaluating the performance of the HCA-N solution in terms of the incidence of delayed recovery of transplant kidney function and the speed of early renal function recovery, with the aim of providing better preservation solution selection and high-level evidence-based guidance for clinical practice in kidney transplantation.
详细描述
Study Title：A Multicenter, Randomized, Double-Blind, Positive-Controlled, Non-Inferiority Clinical Trial to Evaluate the Efficacy and Safety of HCA-N Solution for Preservation of Donor Kidneys in Renal Transplantation Study Design：Multicenter, randomized, double-blind, positive-controlled, non-inferiority trial Device Name：Test Group: HCA-N Solution；Control Group: HTK Solution； Regulatory Classification：Class III Study Objective：To evaluate the safety and efficacy of HCA-N Solution for the preservation of donor kidneys in renal transplantation, through a comparative study with HTK Solution in kidney organ transplantation.
Indication for Use：This product is intended for flushing and preserving isolated kidneys for clinical renal transplantation.
Sample Size：250 subjects in total, with 125 subjects in each of the test and control groups.
Study Centers：Approximately 20 centers Primary Endpoint：(1)Percentage of subjects experiencing delayed graft function (DGF) post-transplantation. (2)DGF is defined as the need for dialysis within 1 week after transplantation.
Secondary Endpoints：(1)Percentage of subjects with eGFR > 30 mL/(min·1.73 m²) within 28 days post-transplantation;(2)Time to first eGFR > 30 mL/(min·1.73 m²) within 28 days post-transplantation;(3)Change in eGFR from baseline (the last value before transplantation) at Days 1, 3, 7, 14, and 28 post-transplantation;(4)Device deficiencies.
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
- Double (Participant, Investigator)
盲法说明
Masking Description
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
- •Recipients must meet all of the following criteria 1-4:(1)Age 18 to 65 years (inclusive), regardless of gender;(2)Diagnosed as eligible for allogeneic renal transplantation and willing to undergo allogeneic renal transplantation;(3)Understand and agree to comply with the study requirements and voluntarily sign the informed consent form;(4)Require renal transplantation and be first-time transplant recipients.
- •Donors must meet all of the following criteria 5-6:(5)Donor kidney source aged 18 to 65 years (inclusive), regardless of gender;(6)Donor's last serum creatinine before kidney procurement < 2 mg/dL (177 μmol/L), and not having received hemodialysis.
排除标准
- •(Recipients meeting any of the following criteria 1-8 will be excluded):(1)Planned for dual kidney transplantation;(2)Planned for multi-organ combined transplantation;(3)History of previous organ transplantation;(4)Concurrent severe diseases, such as severe hepatic impairment, cardiopulmonary insufficiency, coagulation disorders, etc.;(5)Diagnosis of malignant tumor within 5 years prior to enrollment (except for adequately treated cervical carcinoma in situ, localized cutaneous squamous cell carcinoma, basal cell carcinoma, prostate cancer not requiring antitumor therapy, thyroid cancer, breast ductal carcinoma in situ, and urothelial carcinoma below T1 stage);(6)Panel reactive antibody (PRA) > 10%;(7)Pregnant or lactating women;(8)Participation in other drug or device clinical trials within 3 months prior to enrollment.
- •Donors meeting any of the following criteria will be excluded:(1)Donor has received renal replacement therapy (hemodialysis/CRRT) prior to screening;(2)Donor has infectious diseases unsuitable for transplantation.(3)Other requirements:ABO blood type incompatibility between donor and recipient;Donor kidney warm ischemia time > 10 min, or cold ischemia time > 24 h;Mechanical perfusion preservation required as assessed by the investigator;Other conditions that the investigator deems inappropriate for participation in this trial.
研究组 & 干预措施
Evaluate the Efficacy and Safety of HCA-N Solution for Preservation of Donor Kidneys
To evaluate the safety and efficacy of HCA-N Solution for the preservation of donor kidneys in renal transplantation, through a comparative study with HTK Solution in kidney organ transplantation.
干预措施: HCA-N Solution (Drug)
comparative with HTK Solution in kidney organ transplantation.
The commonly used methods in clinical practice
干预措施: HTK Solution (Drug)
结局指标
主要结局
Percentage of subjects experiencing delayed graft function (DGF) post-transplantation.
时间窗: Baseline at Days 1, 3, 7, 14, and 28 post-transplantation
DGF is defined as the need for dialysis within 1 week after transplantation.
次要结局
未报告次要终点