Perioperative Ursodeoxycholic Acid for Renal Protection in Adults Undergoing Partial Nephrectomy for Renal Tumors

NCT07672860 | Recruiting Phase 2

• 1 other identifier: 2025DZKY-180-02
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is perioperative UDCA administration safe in patients undergoing surgery for renal tumors?
2. 2.Does UDCA lower the risk of acute kidney injury within 48 hours after partial nephrectomy?
3. 3.Does UDCA reduce the decline in kidney function after surgery?
4. 4.Does UDCA increase blood levels of UDCA and related bile acids during the perioperative period?
5. 5.What medical problems do participants have when taking UDCA around the time of surgery?
6. 6.Researchers will also evaluate whether UDCA affects urinary biomarkers of kidney injury.
7. 7.Take UDCA or a placebo three times a day from 2 days before surgery until 5 days after surgery.
8. 8.Undergo partial nephrectomy as planned by their treating surgeon.
9. 9.Have blood tests before and after surgery to check kidney function, liver function, and bile acid levels.
10. 10.Participants will provide urine samples before and after surgery for the assessment of kidney injury biomarkers.
11. 11.Be monitored for side effects, surgical complications, and other medical problems during hospitalization and follow-up.

Conditions

Kidney Cancer

Keywords

ursodeoxycholic acid; Ischemia-reperfusion injury; Acute kidney injury; perioperative; partial nephrectomy

Outcome Measures

Primary Outcomes (1)

• Incidence of AKI within 48 hours after surgery

  Defined according to the serum creatinine criterion of the KDIGO criteria

  From baseline to 48 hours after surgery.

Secondary Outcomes (12)

• Incidence of AKI within 48 hours after surgery（Defined according to either the serum creatinine or urine output criterion of the KDIGO criteria）

  From baseline to 48 hours after surgery.

• Between-group difference in mean eGFR on postoperative day 1

  From baseline to 24 hours after surgery.

• Between-group difference in mean eGFR on postoperative day 2

  From baseline to 48 hours after surgery.

• Maximum absolute increase in serum creatinine from baseline within 48 hours after surgery

  From baseline to 48 hours after surgery.

• Perioperative complications

  Perioperatively

Other Outcomes (2)

• Change from baseline in serum UDCA concentration

  Perioperatively

• Perioperative changes in urinary NGAL biomarker levels

  Perioperatively

Study Arms (2)

UDCA

EXPERIMENTAL

Participants will receive UDCA （250 mg, tid）

Drug: UDCA (Ursodeoxycholic acid)

placebo

PLACEBO COMPARATOR

Participants will receive placebo（1 capsule tid）

Drug: Placebo

Interventions

UDCA (Ursodeoxycholic acid) DRUG

Ursodeoxycholic 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.

UDCA

Placebo DRUG

1 capsule tid. Placebo will be administered orally three times daily, starting 2 days before surgery and continuing through postoperative day 5.

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;
• No history of allergy or intolerance to UDCA or other bile acid preparations, and no UDCA contraindications or biliary tract-related diseases that, in the investigator's judgment, would make the patient unsuitable for UDCA treatment;
• The subject is willing and able to comply with the scheduled visits, treatment, laboratory tests, and other study-related procedures required by the protocol.

You may not qualify if:

• Patients meeting any of the following criteria will be excluded from the study:
• 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;
• Continuous or systemic use of nephrotoxic drugs for more than 1 week within 3 months before screening, including but not limited to nonsteroidal anti-inflammatory drugs and aminoglycoside antibiotics;
• Continuous or systemic use of drugs that may significantly affect the gut microbiota or bile acid metabolism within 1 month before screening, including antibiotics, probiotics, high-dose glucocorticoids, immunosuppressants, potent laxatives, or antidiarrheal agents;
• Participation in another interventional clinical study within 3 months before screening, or ongoing treatment with another investigational drug or device;
• Uncontrolled active infection during the screening period, including but not limited to urinary tract infection, pulmonary infection, intra-abdominal infection, or systemic infection;
• Uncontrolled blood pressure abnormalities during the screening period, including mean seated SBP ≥180 mmHg or DBP ≥110 mmHg; symptomatic hypotension, SBP \<90 mmHg, or hypovolemia as judged by the investigator;
• History of New York Heart Association (NYHA) class III-IV heart failure, or hospitalization due to heart failure/fluid retention within 6 months before screening;

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms; Reperfusion Injury; Acute Kidney Injury

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Central Study Contacts

Qu Le M.D

CONTACT

+86 15720625951; septsoul@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief urologist

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: June 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)