Kidney Transplant Clinical Trials

Clinical trials related to Kidney Transplant Procedure

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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
Contact Information
Primary
Weiyang He, MD
weiyang361@163.com
+86 023-89012012
Time Frame
Start Date: 2025-12-10
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 47
Treatments
Experimental: Vonoprazan Fumarate
Related Therapeutic Areas
Sponsors
Collaborators: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Leads: First Affiliated Hospital of Chongqing Medical University

This content was sourced from clinicaltrials.gov