Phase 2 Chronic Kidney Disease 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:

• Adults between 18 and 65 years old who are planning to receive a single kidney transplant from a living donor.
• The living kidney donor must also be between 18 and 65 years old. A close tissue match between donor and recipient is not required.
• The donor and recipient must have compatible blood types (for example, a recipient with blood type O must receive from a donor with blood type O).
• People who have never had any organ transplant before.
• Women who could become pregnant must agree to use an approved form of birth control throughout the trial.
• Male participants must agree to use birth control from the start of their transplant medicines and for at least 6 months after the kidney transplant.
• Participants must be able to understand and sign a consent form before any trial procedures begin.
• If the donor is required by the reviewing ethics board to give consent, the donor must also be able to understand and sign a consent form.

Who may not be able to join:

• People who have a known allergy or medical reason to avoid certain immunosuppression medications used in this trial, including thymoglobulin, everolimus, sirolimus, or tacrolimus.
• People whose pre-transplant blood tests show immune system reactions that could attack the donor kidney (positive crossmatch results).
• People whose immune sensitisation level (PRA) is above 80% based on pre-transplant testing.
• People who currently have, or have previously had, antibodies specifically targeting the donor's tissue.
• People whose body mass index (BMI) is below 16 or above 38.
• People who are pregnant or breastfeeding.
• People whose overall life expectancy is severely limited by conditions other than kidney disease, as judged by the trial doctor.
• People with ongoing active drug or alcohol misuse, as judged by the trial doctor.
• People with a significant ongoing psychiatric condition, or a recent history of not following their current medical treatment, as judged by the trial doctor.
• People with serious heart or cardiovascular conditions, including severely blocked arteries that cannot be corrected, a heart pumping function below 30%, a heart attack within the past 12 months, a heart procedure within the past 3 months, or a heart rhythm problem requiring a pacemaker or ongoing medication.
• People who need to take ongoing blood-thinning (anticoagulant) medications. Blood-thinning medications taken to prevent clots (anti-platelet medications) are allowed if there is no documented heart rhythm problem.
• People who have had a cancer diagnosis within the past 3 years, with the exception of certain common skin cancers (basal cell or squamous cell carcinoma).
• People who have active hepatitis C (HCV), HIV, or hepatitis B (HBV) infection based on pre-transplant blood tests.
• People whose blood test results fall outside certain acceptable ranges for white blood cells, platelets, fats (triglycerides and cholesterol), or blood clotting measures (confirm specific values with trial site).
• People whose kidney disease is considered high risk for returning after transplant, such as certain conditions like primary focal segmental glomerulosclerosis, or others as determined by the trial doctor.
• People who need ongoing immune-suppressing medications to manage their kidney disease or other conditions such as inflammatory bowel disease. People using inhaled corticosteroids (such as for asthma) are allowed.
• People with diabetes who have a blood sugar control level (HbA1c) above 8%.
• People who have an active infection that has not cleared before the transplant.
• People in the treatment arm involving a cell collection procedure who have an active significant infection, a PRA above 80% on repeat testing, are pregnant or breastfeeding, have taken an experimental drug or anti-T cell therapy within the past 30 days, or do not meet the institution's pre-procedure safety requirements.
• People in the treatment arm involving a cell infusion who have an active significant infection, a new serious medical condition, a rejection episode of the transplanted kidney before the infusion, are pregnant or breastfeeding (a negative pregnancy test is required before infusion), or have taken an experimental drug or anti-T cell therapy within the past 30 days.

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