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.
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;
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;
Parallel
UDCA (Ursodeoxycholic acid)
DrugUrsodeoxycholic Acid Capsules 250 mg, 1 capsule tid. UDCA will be administered orally three times daily, starting 2 days before surgery and continuing through postoperative day 5.
Placebo
Drug1 capsule tid. Placebo will be administered orally three times daily, starting 2 days before surgery and continuing through postoperative day 5.
Incidence of AKI within 48 hours after surgery
Defined according to the serum creatinine criterion of the KDIGO criteria
Incidence of AKI within 48 hours after surgery（Defined according to either the serum creatinine or urine output criterion of the KDIGO criteria）
Defined according to either the serum creatinine or urine output criterion of the KDIGO criteria
Between-group difference in mean eGFR on postoperative day 1
This endpoint will be assessed using an analysis of covariance model
Between-group difference in mean eGFR on postoperative day 2
This endpoint will be assessed using an analysis of covariance model
Maximum absolute increase in serum creatinine from baseline within 48 hours after surgery
Maximum absolute increase = highest postoperative serum creatinine within 48 hours - baseline serum creatinine
Change from baseline in serum UDCA concentration
Change from baseline to postoperative day 1
Perioperative changes in urinary NGAL biomarker levels
Change from baseline to postoperative day 1
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