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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllFirst Affiliated Hospital of Chongqing Medical Unโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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 f

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 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).
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What it tests

  • Vonoprazan fumarate
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Where

2 sites
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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