Phase 2 Kidney Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have read and understood the study information and have agreed to take part by signing a consent form
• Men or women between 18 and 75 years old at the time of signing the consent form
• People whose scans (MRI or CT) show a stage T1 kidney tumour (an early-stage tumour confined to the kidney)
• People whose pre-surgery scans show no sign that the tumour has grown into the kidney's internal drainage system
• People whose doctor has assessed them and planned for them to have a surgery called partial nephrectomy or renal tumour enucleation (operations that remove the tumour while keeping the rest of the kidney)
• People whose surgery is planned to involve temporarily clamping the main kidney artery (a standard technique used during this type of surgery)
• People whose surgery will be performed by a surgeon who has carried out at least 50 of these kidney operations before, using a standard clamping method
• People whose kidney function test (called eGFR) shows a result of 30 or above at the screening stage
• People with no known allergy, intolerance, or medical reason preventing them from taking a medication called UDCA (a bile acid preparation used in this trial)
• People who are able and willing to attend all scheduled visits, take all treatments, and follow all study procedures as required

Who may not be able to join:

• People who need emergency surgery (surgery required within 24 hours for urgent medical reasons)
• People assessed before surgery as having a high risk of bleeding, or whose surgery is expected to involve complex kidney reconstruction, where the investigating doctor considers participation unsuitable
• People whose surgery is planned to use non-standard techniques that avoid or limit artery clamping (such as selective or zero-ischemia approaches)
• People who have previously had surgery on either kidney, or who have had a kidney transplant
• People who have only one kidney
• People who have had major surgery on an abdominal organ within the past year, where the investigating doctor considers this may affect the current surgery or study assessments
• People with active kidney conditions or significant kidney abnormalities on imaging that could affect kidney function assessment or surgical risk — examples include narrowed kidney arteries, polycystic kidney disease, chronic kidney infection, severe fluid build-up in the kidney, or a shrunken kidney
• People who have taken UDCA, related bile acid medications, or drugs that significantly affect bile acid processing within one month before screening
• People who have taken kidney-harmful drugs continuously for more than one week in the three months before screening — examples include certain anti-inflammatory painkillers and a class of antibiotics called aminoglycosides
• People who have continuously taken medications that significantly affect gut bacteria or bile acid processing within one month before screening — examples include antibiotics, probiotics, high-dose steroids, immune-suppressing drugs, strong laxatives, or anti-diarrhoeal medicines
• People who have taken part in another interventional clinical trial within the three months before screening, or who are currently receiving another experimental treatment or device
• People with an uncontrolled active infection at the time of screening — examples include urinary tract, lung, abdominal, or widespread body infections
• People with uncontrolled blood pressure problems at the time of screening, including very high blood pressure (top reading at or above 180, or bottom reading at or above 110), symptoms of low blood pressure (top reading below 90), or low blood volume as assessed by the doctor
• People with a history of moderate-to-severe heart failure (classified as NYHA class III or IV), or who have been hospitalised for heart failure or fluid retention in the six months before screening
• People with significant liver disease, including a history of liver-related brain problems, bleeding from oesophageal or stomach veins, certain types of liver bypass surgery, severe liver impairment (Child-Pugh class C), or liver enzyme or bilirubin levels significantly above normal at screening
• People with conditions or surgical history that may significantly affect how the study drug is absorbed or processed by the body, including: active inflammatory bowel disease in the past six months; previous major gut surgery such as stomach removal or bowel resection; stomach or bowel ulcers or bleeding in the past six months; or pancreas injury or inflammation in the past six months
• Women who are pregnant or breastfeeding
• Women who could become pregnant and either had a positive pregnancy test at screening, or are unwilling to use effective contraception during the study
• People with a history of other cancers, except for cancers confirmed to have been cured or in remission for five or more years, certain fully removed skin cancers, or non-invasive cancers (carcinoma in situ) at any location
• People with any other serious or uncontrolled medical condition, mental health condition, or abnormal test result that could increase the risks of participation, affect the person's ability to follow the study, or make the results harder to interpret — examples include organ failure, uncontrolled immune system disease, active uncontrolled hepatitis B, hepatitis C, or HIV infection, cognitive impairment, or severe psychiatric illness

Important: Always verify eligibility with the trial site directly before applying.