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 aged 16 to 85 years who have end-stage kidney disease and are being considered for a kidney transplant, including those already on dialysis or approaching the need for it.
• People whose overall health has been assessed by doctors as suitable for transplant surgery and for taking anti-rejection medications afterward.
• People for whom a kidney from a deceased donor is available that meets standard quality requirements and is a compatible blood type, and where the donated kidney can be made available for the gene-editing process before transplant.
• People who are able to understand the experimental nature of the study and have willingly signed a consent form, and who are willing to attend all required visits and tests.
• People who have no pre-existing immune reaction against the specific donor kidney that would cause immediate rejection — confirmed through standard crossmatch testing before the transplant.
• Women who could become pregnant must have a negative pregnancy test and must agree to use effective contraception during the study and for a defined period afterward (confirm with trial site for exact timeframe); men whose partners could become pregnant must also agree to use contraception.
• People with a high level of immune sensitivity to donor organs — for example, those with a calculated panel reactive antibody (PRA) level above 80%, meaning they have had difficulty finding a compatible donor due to prior transplants, blood transfusions, or pregnancies — are specifically anticipated to be eligible, provided they still pass the crossmatch requirement above.
• People who are able to attend long-term follow-up appointments at a study centre in China, or who are able to travel there for scheduled visits, and who are willing to stay near the transplant centre during the early recovery period.

Who may not be able to join:

• People with a serious active infection at the time of transplant — such as untreated tuberculosis, uncontrolled hepatitis B or C, or HIV that is not well managed — that could be made worse by anti-rejection medications. (People with well-controlled HIV on stable treatment may be considered individually — confirm with trial site.)
• People who are currently pregnant or breastfeeding, due to the risks that anti-rejection medications and the experimental intervention may pose to a baby or fetus.
• People who need more than one organ transplanted at the same time — for example, a kidney and a heart together — as this trial focuses only on kidney transplants alone.
• People with serious additional health conditions that would make surgery particularly unsafe or make results difficult to interpret, such as recent heart attack, severe heart failure, uncontrolled diabetes with widespread organ damage, or severe liver disease.
• People who cannot safely take standard anti-rejection medications — for example, due to a history of severe allergic reactions to those drugs that cannot be managed, or an existing infection that would become life-threatening with immunosuppression.
• People with significant mental health conditions, cognitive difficulties, or personal circumstances that would make it unlikely they could follow the study requirements or attend follow-up visits, including people who cannot give informed consent.
• People who have previously received an investigational gene therapy, or who are currently taking part in another experimental transplant treatment, as this could make it difficult to determine whether outcomes were caused by this trial's intervention.
• People with significantly abnormal blood test results at the start of the study — such as very low white blood cell or platelet counts, or blood clotting problems — that could increase the risks of surgery or anti-rejection medications.
• If the donated kidney is found to be unsuitable for the gene-editing process or for transplant at the time it is retrieved, the transplant under this study would not proceed for that patient; a decision about next steps would be made at that time (confirm with trial site).

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