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New treatment option for Kidney Cancer
Official title Perioperative Ursodeoxycholic Acid for Renal Protection in Adults Undergoing Partial Nephrectomy for Renal Tumors
ClinicalTrials.gov ID: NCT07672860
What this study is testing
What is UDCA (Ursodeoxycholic acid)?
UDCA (Ursodeoxycholic acid) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for kidney cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1\. Patients must meet all of the following criteria to be eligible for inclusion in the study:
- 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;
You likely can't join 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...
- Patients for whom non-standard ischemia techniques, such as selective/segmental arterial clamping or zero-ischemia techniques, are planned...
- Patients with a history of renal surgery on either kidney or previous kidney transplantation;
- Solitary kidney;
See the full eligibility criteria
- 1\. Patients must meet all of the following criteria to be eligible for inclusion in the study:
- 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...
- The subject is willing and able to comply with the scheduled visits, treatment, laboratory tests, and other study-related procedures required by the protocol. 2\.
- 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...
- 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...
- 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...
- Participation in another treatment 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;
- Hepatic impairment, defined as meeting any of the following criteria: history of hepatic encephalopathy, history of esophagogastric varices, history of portocaval shunt surgery, Child-Pugh class C hepatic impairment...
- Diseases or surgical history that may significantly affect the absorption, distribution, metabolism, or excretion of the study drug, including but not limited to: 1\. history of active inflammatory bowel disease within...
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.