The Effects of Vonoprazan Fumarate on DGF Incidence in DD Kidney Transplant Recipients (NCT07275632) | Clinical Trial Compass
RecruitingPhase 1/2
The Effects of Vonoprazan Fumarate on DGF Incidence in DD Kidney Transplant Recipients
China47 participantsStarted 2025-12-10
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Delayed Graft Function (DGF)
Timeframe: Within the first 7 days post-transplant
Trial details
NCT IDNCT07275632
SponsorFirst Affiliated Hospital of Chongqing Medical University