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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: weiyang361@163.com
• Phone: +86 023-89012012

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.