Actively Recruiting
The Effects of Vonoprazan Fumarate on DGF Incidence in DD Kidney Transplant Recipients
Led by First Affiliated Hospital of Chongqing Medical University · Updated on 2025-12-23
47
Participants Needed
2
Research Sites
55 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Chongqing Medical University
Lead Sponsor
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effects of Vonoprazan Fumarate on DGF Incidence in DD Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 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.
You will not qualify if you...
- 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).
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Actively Recruiting
2
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Not Yet Recruiting
Research Team
W
Weiyang He, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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