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NCT07275632

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

Recruiting now Phase 1, PHASE2 Last updated 23 December 2025
What this trial tests

Phase 1, PHASE2 trial testing Vonoprazan fumarate in Delayed Graft Function in 47 participants. Currently enrolling.

Timeline
10 December 2025
Primary endpoint
31 October 2026
31 December 2026

Quick facts

Lead sponsorFirst Affiliated Hospital of Chongqing Medical University
PhasePhase 1, PHASE2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment47
Start date10 December 2025
Primary completion31 October 2026
Estimated completion31 December 2026
Sites2 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

First Affiliated Hospital of Chongqing Medical University

Who can join

18 and older, any sex, with Delayed Graft Function or Kidney Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Vonoprazan fumarate

Trials testing the same drug.

Other recruiting trials for Delayed Graft Function

Currently open trials in the same condition.

Other First Affiliated Hospital of Chongqing Medical University trials

Trials by the same sponsor.

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Data sources for this page

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