A Phase 2 interventional study of UDCA (Ursodeoxycholic acid) and Placebo in Kidney Cancer, sponsored by Jinling Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Jinling Hospital, China · Phase 2, Interventional, and Treatment
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:
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:
Partial nephrectomy (PN) is the preferred nephron-sparing surgical approach for T1 renal tumors, providing oncological outcomes comparable to those of radical nephrectomy while better preserving renal function. However, temporary renal artery clamping during PN may induce renal ischemia-reperfusion injury (IRI), thereby increasing the risk of postoperative acute kidney injury and long-term renal functional decline. Currently, no pharmacological intervention has been proven to provide definitive and effective perioperative renal protection in patients undergoing PN. Ursodeoxycholic acid (UDCA), an endogenous bile acid, has a well-established safety profile and good clinical accessibility. Previous studies in experimental models of kidney injury have shown that UDCA may exert renoprotective effects through mechanisms including amelioration of mitochondrial dysfunction, attenuation of oxidative stress and inflammatory responses, and improvement of impaired fatty acid oxidation.
This study aims to evaluate whether perioperative administration of UDCA can attenuate renal injury caused by ischemia-reperfusion during PN. In addition, by monitoring renal function, liver function, bile acid levels, and relevant kidney injury biomarkers, this study will comprehensively assess the efficacy and safety of perioperative UDCA administration, thereby providing evidence for its potential application in perioperative renal protection in kidney surgery.
Before the randomized phase begins, the first six enrolled patients will receive UDCA treatment and will be observed and evaluated as part of a safety run-in phase. Participants in this phase will be included in the safety analysis but will not be included in the final efficacy analysis of the randomized phase. If no unacceptable safety risks are identified during the safety run-in phase, the study will proceed to the randomized, double-blind, placebo-controlled phase.
After completion of the safety analysis, investigators will screen all patients scheduled to undergo PN at the time of hospital admission. Patients who meet the eligibility criteria and voluntarily agree to participate in the study will be randomized after providing written informed consent.
969 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's planned enrollment of 162 is above the median of 46 across 668 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →Jinling Hospital, China is the lead sponsor of 131 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
1. Inclusion Criteria
Patients must meet all of the following criteria to be eligible for inclusion in the study:
2. Exclusion Criteria
Patients meeting any of the following criteria will be excluded from the study:
1. history of active inflammatory bowel disease within the previous 6 months; 2. history of major gastrointestinal surgery, such as gastrectomy, gastrointestinal anastomosis, or bowel resection; 3. history of gastrointestinal ulcer and/or gastrointestinal or rectal bleeding within the previous 6 months; 4. history of pancreatic injury or pancreatitis within the previous 6 months; (17) Pregnant or breastfeeding women; (18) Women of who have a positive pregnancy test during the screening period, or who are unwilling to use effective during the study; (19) Patients with a history of other are excluded, except for malignancies confirmed to have been cured or in remission for ≥5 years, radically resected basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ at any site； (20) Any other severe or uncontrolled medical disease, psychiatric disorder, or laboratory abnormality that may increase the risk associated with study participation, affect subject compliance, or interfere with the interpretation of study results, including but not limited to organ failure, active or uncontrolled immunodeficiency disease, active or uncontrolled // infection, cognitive impairment, or severe psychiatric disorder.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive UDCA （250 mg, tid）
Drug: UDCA (Ursodeoxycholic acid)
Participants will receive placebo（1 capsule tid）
Drug: Placebo
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.
1 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
Time frame: From baseline to 48 hours after surgery.
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
Time frame: From baseline to 48 hours after surgery.
Between-group difference in mean eGFR on postoperative day 1
This endpoint will be assessed using an analysis of covariance model
Time frame: From baseline to 24 hours after surgery.
Between-group difference in mean eGFR on postoperative day 2
This endpoint will be assessed using an analysis of covariance model
Time frame: From baseline to 48 hours after surgery.
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
Time frame: From baseline to 48 hours after surgery.
Perioperative complications
Assessed according to the Clavien-Dindo classification
Time frame: Perioperatively
UDCA-related adverse events
Including gastrointestinal reactions, hepatobiliary abnormalities, skin reactions, and allergic reactions
Time frame: From the first administration of the study drug until 7 days after the last administration.
Change From Baseline in ALT Levels
Change from baseline in ALT levels will be calculated as the ALT value at postoperative assessment time point minus the corresponding baseline value.
Time frame: Perioperatively
Change From Baseline in AST Levels
Change from baseline in AST levels will be calculated as the AST value at postoperative assessment time point minus the corresponding baseline value.
Time frame: Perioperatively
Between-group differences in serum cystatin C on postoperative day 1
Time frame: From baseline to 24 hours after surgery.
Between-group differences in serum cystatin C on postoperative day 2
Time frame: From baseline to 48 hours after surgery.
Maximum AKI stage within 48 hours after PN
according to the 2012 KDIGO serum creatinine criteria
Time frame: From baseline to 48 hours after surgery.
Between-group difference in mean affected-kidney eGFR at 6 months after surgery
This endpoint will be assessed using an analysis of covariance model.
Time frame: at 6 months after surgery
Acute Ipsilateral Renal Dysfunction spectrum score (AIRD)
Time frame: at 6 months after surgery
Ischemia Recovery Index (IRI)
Time frame: at 6 months after surgery
Affected-kidney eGFR recovery rate
Time frame: at 6 months after surgery
Incidence of a ≥25% decline from baseline in eGFR within 1 year after surgery
Time frame: Baseline to 1 year after surgery
Change from baseline in serum UDCA concentration
Change from baseline to postoperative day 1
Time frame: Perioperatively
Perioperative changes in urinary NGAL biomarker levels
Change from baseline to postoperative day 1
Time frame: Perioperatively
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.
Of 64 non-industry phase 2 interventional studies under Kidney Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 112. This study's planned 6 months is below that.
Counting every sponsor, half of 74 studies reached it within 67 months; a quarter within 36 and three quarters within 112.
Primary completion moved once since we started tracking on Sep 25, 2026: Oct 2026 → Dec 2026, on Oct 15, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Ursodeoxycholic Acid