Perioperative Ursodeoxycholic Acid for Renal Protection in Adults Undergoing Partial Nephrectomy … (NCT07672860) | Clinical Trial Compass
RecruitingPhase 2
Perioperative Ursodeoxycholic Acid for Renal Protection in Adults Undergoing Partial Nephrectomy for Renal Tumors
China146 participantsStarted 2026-06-01
Plain-language summary
The goal of this clinical trial is to learn if ursodeoxycholic acid, also called UDCA, can help protect kidney function in adults undergoing partial nephrectomy for kidney tumors. It will also learn about the safety of UDCA when used around the time of surgery.
Before the randomized part of the study begins, the first 6 participants will receive UDCA in a safety run-in phase. These participants will be closely monitored for side effects, laboratory abnormalities, and other medical problems to assess the preliminary safety and tolerability of perioperative UDCA administration. If no unacceptable safety concerns are identified, the study will proceed to the randomized, placebo-controlled phase.
The main questions this study aims to answer are:
1. Is perioperative UDCA administration safe in patients undergoing surgery for renal tumors?
2. Does UDCA lower the risk of acute kidney injury within 48 hours after partial nephrectomy?
3. Does UDCA reduce the decline in kidney function after surgery?
4. Does UDCA increase blood levels of UDCA and related bile acids during the perioperative period?
5. What medical problems do participants have when taking UDCA around the time of surgery?
6. Researchers will also evaluate whether UDCA affects urinary biomarkers of kidney injury.
Researchers will compare UDCA with a placebo, a look-alike substance that contains no active drug, to see if UDCA can help protect the kidney from ischemia-reperfusion injury during partial nephrectomy.
Participants will:
1. Take UDCA or a placebo three times a day from 2 days before surgery until 5 days after surgery.
2. Undergo partial nephrectomy as planned by their treating surgeon.
3. Have blood tests before and after surgery to check kidney function, liver function, and bile acid levels.
4. Participants will provide urine samples before and after surgery for the assessment of kidney injury biomarkers.
5. Be monitored for side effects, surgical complications, and other medical problems during hospitalization and follow-up.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The patient has fully understood the study and has voluntarily signed the informed consent form (ICF);
. Male or female patients aged 18 to 75 years, inclusive, at the time of signing the ICF;
. Imaging diagnosis consistent with stage T1 renal tumor, as assessed by MRI or CT;
. No definite collecting system invasion on preoperative MRI or CT assessment;
. The patient is scheduled to undergo partial nephrectomy (PN) or renal tumor enucleation after clinical evaluation by the physician and full discussion with the patient;
. Preoperative assessment indicates that main renal artery clamping with warm ischemia is planned;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of AKI within 48 hours after surgery
Timeframe: From baseline to 48 hours after surgery.
. The surgery will be performed by a surgeon with experience in at least 50 cases of PN or renal tumor enucleation, and renal artery clamping will be performed using standardized vascular clamp application;
. Screening eGFR ≥30 mL/min/1.73 m², calculated using the CKD-EPI equation;
Exclusion criteria
. Emergency surgery, defined as surgery required for medical reasons within 24 hours;
. Patients who are considered preoperatively to have a significant risk of bleeding, or whose surgery is expected to require complex renal reconstruction, and who are judged by the investigator to be unsuitable for participation in this study;
. Patients for whom non-standard ischemia techniques, such as selective/segmental arterial clamping or zero-ischemia techniques, are planned preoperatively;
. Patients with a history of renal surgery on either kidney or previous kidney transplantation;
. Solitary kidney;
. History of major abdominal organ surgery within 1 year before surgery, which, in the investigator's judgment, may affect the conduct of the current surgery, safety assessment, or evaluation of study endpoints;
. Active lesions or clinically significant imaging abnormalities in either kidney that may substantially affect renal function assessment or perioperative AKI risk evaluation, including but not limited to renal artery stenosis, polycystic kidney disease, chronic pyelonephritis, severe hydronephrosis, or renal atrophy;
. Use of UDCA, chenodeoxycholic acid, bile acid sequestrants, or other drugs that may significantly affect bile acid metabolism within 1 month before screening;