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

Sponsor
Jinling Hospital, China
Study ID
NCT07672860
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Jun 29, 2026
Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
146 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: UDCA
    Participants will receive UDCA （250 mg, tid）
  • Placebo Comparator: placebo
    Participants will receive placebo（1 capsule tid）

Primary Outcome Measure

Incidence of AKI within 48 hours after surgery [ Time Frame: From baseline to 48 hours after surgery. ]

Central Contacts

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