Perioperative Ursodeoxycholic Acid for Renal Protection in Adults Undergoing Partial Nephrectomy for Renal Tumors
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjent świadomie zgadza się na udział w badaniu.
- •Osoby w wieku 18-75 lat z guzem nerki widocznym w badaniach obrazowych (np. rezonansie).
- •Guz nerki nie nacieka układu zbierającego nerki.
- •Pacjent ma zaplanowaną operację częściowego usunięcia guza nerki.
- •Przed operacją planowane jest czasowe zatrzymanie dopływu krwi do nerki.
- •Operację wykonuje doświadczony chirurg.
- •Wydolność nerek przed operacją jest wystarczająca (eGFR ≥30).
- •Brak historii alergii na kwasy żółciowe lub przeciwwskazań do ich stosowania.
✗ Disqualifies
- •Pilne operacje wymagane w ciągu 24 godzin.
- •Pacjenci z dużym ryzykiem krwawienia lub skomplikowaną operacją.
- •Planowane nietypowe metody zatrzymania dopływu krwi do nerki.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- June 29, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing
Nanjing, China
Trial contact
Qu Le M.D
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.