Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT07275632
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07275632
Study Brief:
Protocol Section:
NCT07275632