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New treatment option for Delayed Graft Function
Official title The Effects of Vonoprazan Fumarate on DGF Incidence in DD Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT07275632
What this study is testing
What is Vonoprazan fumarate?
Vonoprazan fumarate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for delayed graft function.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
- people 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).
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, China
- Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, China; Guangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.