Delayed Graft FunctionPhase 1/2NCT07275632
The Effects of Vonoprazan Fumarate on DGF Incidence in DD Kidney Transplant Recipients
A Phase 1/2 study testing Vonoprazan fumarate in people with Delayed Graft Function and Kidney Transplantation, run by First Affiliated Hospital of Chongqing Medical University at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Graft Function, Kidney Transplantation
- What is being tested?
- Vonoprazan fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesChina
- Study dates
- 10 Dec 2025to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Wei-Yang He, MD, 86-023-8901-2012, weiyang361@163.com
- Not yet recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou
Tianxin Lin, MD, 86-020-8133-2199, lintx@mail.sysu.edu.cn
About this study
Official title: 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 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. This study aims to explore how Vonoprazan Fumarate, a potassium-competitive acid blocker (P-CAB), can potentially improve macrophage phagocytic function, reduce kidney inflammation, and enhance early kidney function recovery.
Patients aged 18 years and older who are undergoing first-time deceased-donor kidney transplantation will be enrolled. Vonoprazan Fumarate will be administered daily starting on the day of transplantation and continuing for seven days post-surgery. The primary endpoint is DGF incidence, while secondary endpoints include kidney function recovery, serum creatinine reduction, estimated glomerular filtration rate, and safety assessments. Adverse events will be monitored, and the study will also explore potential biomarkers for inflammation and graft function.
The study is expected to provide insights into a potential new therapeutic strategy to reduce DGF and improve early kidney transplant outcomes, potentially benefiting future kidney transplant patients by offering a safer and more effective perioperative treatment option.
- Conditions
- Delayed Graft Function, Kidney Transplantation
- Being tested
- Vonoprazan fumarate
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan fumarateDrug
Phase Ib:
A dose escalation study will be initiated with vonoprazan fumarate 20 mg once daily (qd). Two dose groups are planned: 20 mg qd and 20 mg twice daily (bid). According to a "3+3" dose escalation scheme, the first three subjects will receive vonoprazan fumarate 20 mg qd orally, starting on the day of kidney transplantation and continuing until postoperative day 7. Safety and tolerability will be assessed from the day of transplantation through postoperative days 7 and 28.
Phase II:
An expansion study will be conducted at the recommended Phase II dose of vonoprazan fumarate to evaluate the efficacy, safety, and tolerability of the regimen. Vonoprazan fumarate will be administered orally, starting on the day of kidney transplantation and continuing daily until postoperative day 7.
Throughout both the Phase Ib and Phase II stages, all recipients will receive the center's standard immunosuppressive regimen.
| Study group | Role | What they receive |
|---|---|---|
| Vonoprazan Fumarate | Experimental | Not described Receives: Drug: Vonoprazan fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Delayed Graft Function (DGF)
Delayed Graft Function (DGF) is defined as the requirement for any form of dialysis (hemodialysis or peritoneal dialysis) due to renal insufficiency within the first week after kidney transplantation.
Measured: Within the first 7 days post-transplant
Secondary outcomes (4)
The rate of serum creatinine decline
The rate of serum creatinine decline will be calculated on a daily basis from postoperative day 1 to day 7.
Measured: Postoperative days 1 to 7
Estimated Glomerular Filtration Rate (eGFR)
eGFR will be measured daily from postoperative day 1 through day 7.
Measured: Postoperative days 1 to 7
Daily urinary output
Daily urinary output will be recorded from postoperative day 1 through day 7.
Measured: Postoperative days 1 to 7
Incidence of Adverse Events
Adverse events-specifically renal (e.g., acute rejection), gastrointestinal (e.g., bloody stools, acid reflux), and electrolyte imbalance (e.g., hypomagnesemia, hyperkalemia)-will be recorded.
Measured: Fecal routine tests will be performed on postoperative days 3 and 7. All other AEs will be monitored daily during the first 7 postoperative days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start10 Dec 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Graft FunctionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiyang He, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275632
- Sponsor's protocol ID
- ZZ2025-945-01
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07275632
- Acronym / sponsor ID
- ZZ2025-945-01
- Conditions
- Delayed Graft Function, Kidney Transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. This study aims to explore how Vonoprazan Fumarate, a potassium-competitive acid blocker (P-CAB), can potentially improve macrophage phagocytic function, reduce kidney inflammation, and enhance early kidney function recovery.
Patients aged 18 years and older who are undergoing first-time deceased-donor kidney transplantation will be enrolled. Vonoprazan Fumarate will be administered daily starting on the day of transplantation and continuing for seven days post-surgery. The primary endpoint is DGF incidence, while secondary endpoints include kidney function recovery, serum creatinine reduction, estimated glomerular filtration rate, and safety assessments. Adverse events will be monitored, and the study will also explore potential biomarkers for inflammation and graft function.
The study is expected to provide insights into a potential new therapeutic strategy to reduce DGF and improve early kidney transplant outcomes, potentially benefiting future kidney transplant patients by offering a safer and more effective perioperative treatment option.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan Fumarate | Experimental | Drug: Vonoprazan fumarate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vonoprazan fumaratePhase Ib: A dose escalation study will be initiated with vonoprazan fumarate 20 mg once daily (qd). Two dose groups are planned: 20 mg qd and 20 mg twice daily (bid). According to a "3+3" dose escalation scheme, the first three subjects will receive vonoprazan fumarate 20 mg qd orally, starting on the day of kidney transplantation and continuing until postoperative day 7. Safety and tolerability will be assessed from the day of transplantation through postoperative days 7 and 28. Phase II: An expansion study will be conducted at the recommended Phase II dose of vonoprazan fumarate to evaluate the efficacy, safety, and tolerability of the regimen. Vonoprazan fumarate will be administered orally, starting on the day of kidney transplantation and continuing daily until postoperative day 7. Throughout both the Phase Ib and Phase II stages, all recipients will receive the center's standard immunosuppressive regimen. | Drug | Vonoprazan Fumarate |
Primary outcome
Incidence of Delayed Graft Function (DGF)
Time frame: Within the first 7 days post-transplant
Delayed Graft Function (DGF) is defined as the requirement for any form of dialysis (hemodialysis or peritoneal dialysis) due to renal insufficiency within the first week after kidney transplantation.
4 secondary outcomes
The rate of serum creatinine decline
Time frame: Postoperative days 1 to 7
Estimated Glomerular Filtration Rate (eGFR)
Time frame: Postoperative days 1 to 7
Daily urinary output
Time frame: Postoperative days 1 to 7
Incidence of Adverse Events
Time frame: Fecal routine tests will be performed on postoperative days 3 and 7. All other AEs will be monitored daily during the first 7 postoperative days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vonoprazan fumarate in people with Delayed Graft Function and Kidney Transplantation, run by First Affiliated Hospital of Chongqing Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weiyang He, MD (+86 023-89012012, weiyang361@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Delayed Graft Function (DGF) (time frame: Within the first 7 days post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.