The Effects of Vonoprazan Fumarate on DGF Incidence in DD Kidney Transplant Recipients

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Vonoprazan fumarate
  Phase Ib: A dose escalation study will be initiated with vonoprazan fumarate 20 mg once daily (qd). Two dose groups are planned: 20 mg qd and 20 mg twice daily (bid). According to a "3+3" dose escalation scheme, the first three subjects will receive vonoprazan fumarate 20 mg qd orally, starting on the day of kidney transplantation and continuing until postoperative day 7. Safety and tolerability will be assessed from the day of transplantation through postoperative days 7 and 28. Phase II: An

Первичные конечные точки

• Incidence of Delayed Graft Function (DGF) [Срок оценки: Within the first 7 days post-transplant]

Вторичные конечные точки (4)

• The rate of serum creatinine decline [Срок оценки: Postoperative days 1 to 7]
• Estimated Glomerular Filtration Rate (eGFR) [Срок оценки: Postoperative days 1 to 7]
• Daily urinary output [Срок оценки: Postoperative days 1 to 7]
• Incidence of Adverse Events [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 2 центра

• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT07275632 · ZZ2025-945-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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