A Multicenter, Single-Arm, Exploratory Study Evaluating the Effect of Perioperative Oral Vonoprazan Fumarate on the Incidence of Delayed Graft Function in Deceased Donor Kidney Transplant Recipients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Incidence of Delayed Graft Function (DGF)
研究概览
简要总结
This is an exploratory, multicenter, single-arm study designed to evaluate the efficacy of perioperative Vonoprazan Fumarate in reducing the incidence of Delayed Graft Function (DGF) in deceased-donor kidney transplant recipients. DGF is a common early complication that significantly impacts graft function and long-term transplant survival. This study aims to explore how Vonoprazan Fumarate, a potassium-competitive acid blocker (P-CAB), can potentially improve macrophage phagocytic function, reduce kidney inflammation, and enhance early kidney function recovery.
Patients aged 18 years and older who are undergoing first-time deceased-donor kidney transplantation will be enrolled. Vonoprazan Fumarate will be administered daily starting on the day of transplantation and continuing for seven days post-surgery. The primary endpoint is DGF incidence, while secondary endpoints include kidney function recovery, serum creatinine reduction, estimated glomerular filtration rate, and safety assessments. Adverse events will be monitored, and the study will also explore potential biomarkers for inflammation and graft function.
The study is expected to provide insights into a potential new therapeutic strategy to reduce DGF and improve early kidney transplant outcomes, potentially benefiting future kidney transplant patients by offering a safer and more effective perioperative treatment option.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at time of transplantation.
- •Undergoing first-time deceased-donor kidney transplantation.
- •No administration of proton-competitive acid blockers (P-CABs) in the 1 month prior to transplantation.
- •Consent to receive the standard immunosuppressive therapy post-transplantation.
- •Ability and willingness to provide informed consent and comply with study procedures and follow-up.
- •Complete baseline clinical data available.
排除标准
- •Receiving a living-donor kidney transplant or multi-organ transplantation.
- •Previous history of any solid organ or cellular transplantation (with the exception of corneal transplants).
- •Intraoperative occurrence of hyperacute rejection or confirmed graft non-function (e.g., renal artery thrombosis).
- •Presence of high risk for primary graft non-function (e.g., severe injury to the transplant renal artery).
- •Severe postoperative intestinal obstruction requiring prolonged fasting or inability to take oral medication in perioperative period.
- •Known history of hypersensitivity to vonoprazan fumarate or any of its excipients.
- •Subjects with severe hepatic impairment (Child-Pugh Class C).
- •Concomitant use of strong CYP3A4 inhibitors (e.g., ritonavir, clarithromycin).
- •Current therapy with atazanavir or rilpivirine.
- •Any other condition deemed by the investigator to be inappropriate for study participation (e.g., uncontrolled active infection, severe peptic ulcer, pregnancy or lactation).
研究组 & 干预措施
Vonoprazan Fumarate
干预措施: Vonoprazan fumarate (Drug)
结局指标
主要结局
Incidence of Delayed Graft Function (DGF)
时间窗: Within the first 7 days post-transplant
Delayed Graft Function (DGF) is defined as the requirement for any form of dialysis (hemodialysis or peritoneal dialysis) due to renal insufficiency within the first week after kidney transplantation.
次要结局
- The rate of serum creatinine decline(Postoperative days 1 to 7)
- Estimated Glomerular Filtration Rate (eGFR)(Postoperative days 1 to 7)
- Daily urinary output(Postoperative days 1 to 7)
- Incidence of Adverse Events(Fecal routine tests will be performed on postoperative days 3 and 7. All other AEs will be monitored daily during the first 7 postoperative days.)
研究者
Weiyang He
Professor
First Affiliated Hospital of Chongqing Medical University