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:

• People who have given their voluntary agreement to take part in the study and to be followed up for the rest of their life
• People who have been diagnosed with end-stage renal disease (complete kidney failure) at the time of signing up
• People who have been dependent on kidney dialysis (hemodialysis) for at least 6 months and have a working access point for dialysis (such as a fistula, graft, or permanent catheter) in place
• People who are between 50 and 70 years old, OR between 40 and 49 years old with a very high level of antibodies that make finding a matching kidney extremely difficult (a calculated panel reactive antibody score of 99.9% or higher) (confirm with trial site)
• People whose chest scan shows that a gland in the chest called the thymus has shrunk with age, based on a specific measurement (confirm with trial site)
• People who live within 3 hours of travel time from the transplant centre
• Women who have been through menopause or have had a permanent procedure to prevent pregnancy (such as removal of the uterus or ovaries); men who agree to use a highly effective form of contraception if there is any possibility of conception
• People whose blood test shows they have not previously developed antibodies that would react against the donor pig tissue (negative xeno-crossmatch) (confirm with trial site)
• People whose estimated survival after transplant, based on a recognised calculator, is greater than 20%
• People with a body mass index (a measure of weight relative to height) of 35 or below
• People who have completed, or have started and plan to complete, the recommended vaccinations for their age and health situation, including specific meningococcal vaccines
• People whose blood tests show they have previously been exposed to two common viruses: cytomegalovirus (CMV) and Epstein-Barr virus (EBV)

For Group 1 only — people who are not eligible for a standard human kidney transplant for medical reasons, meaning they:

• Are not eligible to receive a kidney from a living donor, OR
• Are not eligible to be placed on the national kidney transplant waiting list, OR
• Have previously been removed from the national kidney transplant waiting list

For Group 2 only — people who:

• Are currently on the national kidney transplant waiting list (in active or inactive status)
• Do not have an approved living kidney donor available
• Are considered more likely to die or remain without a transplant within 5 years than to receive a kidney transplant, based on a recognised decision tool

Who may not be able to join:

• People who need more than one organ transplanted at the same time
• People with serious ongoing health conditions, including but not limited to: chronic liver disease; advanced heart or blood vessel disease; severe circulation problems in the legs that would make surgery technically impossible; severe neurological (brain or nerve) conditions that would prevent meaningful recovery or the ability to give informed consent; a breathing or lung condition that requires regular or ongoing steroid tablets or supplemental oxygen; high blood pressure in the lungs (pulmonary hypertension); diabetes that is not well controlled, or diabetes complications including severe eye disease; or severe bladder problems requiring regular catheter use
• People whose kidney failure was caused by an inherited or structural kidney condition
• People who currently have cancer or have recently been treated for cancer
• People who have a blood disorder causing anaemia that is not related to kidney disease (such as thalassaemia or sickle cell disease)
• People who are unable to stop taking long-term blood-thinning medication (low-dose daily aspirin is permitted)
• People who have a history of a major psychiatric condition involving psychiatric hospitalisation and/or thoughts of suicide within the past 5 years
• People who are currently being treated for active tuberculosis (TB), have received preventive TB treatment for a positive test result, or test positive for TB during the screening process
• People who test positive for hepatitis B virus or hepatitis C virus by a specific type of test; people whose hepatitis B immunity level is below a certain threshold unless they have been confirmed as non-responders to the hepatitis B vaccine after completing all recommended doses; or people who test positive for HIV
• People who are not able to independently carry out basic day-to-day activities on their own
• People who have a history of not following medical instructions, which might make it difficult to meet the demanding requirements of this type of transplant — for example, a history of substance use disorder within the past year, lack of social support, or untreated psychological conditions

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