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Recruiting NCT07275632

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

Phase I / Phase II Interventional Delayed Graft Function Kidney Transplantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vonoprazan fumarate.
Who it may be relevant to
Registry conditions: Delayed Graft Function, Kidney Transplantation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug 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

Primary outcome measures

  • Incidence of Delayed Graft Function (DGF) [Time frame: Within the first 7 days post-transplant]
Secondary outcome measures (4)
  • The rate of serum creatinine decline [Time frame: Postoperative days 1 to 7]
  • Estimated Glomerular Filtration Rate (eGFR) [Time frame: Postoperative days 1 to 7]
  • Daily urinary output [Time frame: Postoperative days 1 to 7]
  • Incidence of Adverse Events [Time frame: 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.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

China · 2 centers
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT07275632 · ZZ2025-945-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗