Vonoprazan to reduce delayed graft function after deceased-donor kidney transplant

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

This trial will test whether giving vonoprazan around the time of surgery lowers the chance of delayed graft function in adults receiving their first deceased-donor kidney transplant.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Chongqing Medical University (Academic / other)
• Locations: 2 sites (Chongqing and 1 other locations)
• Trial ID: NCT07275632 on ClinicalTrials.gov

What this trial studies

This exploratory, multicenter, single-arm Phase 1/2 study gives vonoprazan fumarate starting on the day of transplantation and continuing once daily for seven days to adult recipients of a first deceased-donor kidney. The primary outcome is the incidence of delayed graft function, with secondary outcomes including early serum creatinine decline, eGFR recovery, and safety measures. The rationale is that vonoprazan, a potassium-competitive acid blocker, may improve macrophage phagocytic function and reduce kidney inflammation to promote earlier graft recovery. Participants are enrolled at two tertiary hospitals and followed in-hospital and after discharge to capture clinical and laboratory endpoints.

Who should consider this trial

Good fit: Adults (≥18 years) undergoing their first deceased-donor kidney transplant who have not used P-CABs in the prior month, can take oral medication, and will receive standard post-transplant immunosuppression are eligible.

Not a fit: Patients receiving living-donor or multi-organ transplants, those with intraoperative hyperacute rejection or a high risk of primary graft non-function, or those unable to take oral medication postoperatively are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, perioperative vonoprazan could lower early graft dysfunction rates and speed recovery of kidney function after deceased-donor transplantation.

How similar studies have performed: Using vonoprazan to improve transplant outcomes is largely novel—preclinical and translational data hint that P-CABs can affect macrophage function, but clinical evidence in transplantation is limited.

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).

Where this trial is running

Chongqing and 1 other locations

• The First Affiliated Hospital of Chongqing Medical University — Chongqing, China (Recruiting)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Weiyang He, MD

Conditions Delayed Graft Function; Kidney Transplantation