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

Chongqing Medical University

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Kidney Transplantation

Delayed Graft Function

Treatments

Drug: Vonoprazan fumarate

Study type

Interventional

Funder types

Other

Identifiers

NCT07275632

ZZ2025-945-01

Details and patient eligibility

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.

Enrollment

47 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).