Study of Oral Vonoprazan Fumarate to Reduce Delayed Graft Function After Deceased-Donor Kidney Transplantation

What this Trial Is About

Researchers are exploring the use of Vonoprazan Fumarate in adults undergoing their first deceased-donor kidney transplant to see if it can reduce the occurrence of Delayed Graft Function DGF, a common complication that affects early kidney function and long-term transplant success. This exploratory, multicenter, single-arm study aims to assess how Vonoprazan Fumarate, a potassium-competitive acid blocker, may improve immune cell function, decrease kidney inflammation, and support early kidney recovery. The study involves giving Vonoprazan Fumarate orally starting on the day of transplantation and continuing daily for seven days after surgery. The trial includes a dose escalation phase, beginning with 20 mg once daily and potentially increasing to twice daily, followed by a phase II expansion at the recommended dose. All participants will also receive standard immunosuppressive therapy as per the transplant centers protocol during the study. Participants will be closely monitored for the incidence of DGF within the first seven days after transplant, along with measurements of kidney function such as serum creatinine levels, estimated glomerular filtration rate, and daily urine output. Safety will be tracked through adverse event monitoring, including fecal tests on postoperative days 3 and 7. The studys findings may offer new insights into improving early outcomes for kidney transplant patients over a follow-up period covering at least the first week post-surgery.

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