Early Phase 1 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 have end-stage kidney disease (kidneys no longer work), are on a transplant waiting list, and need a special treatment to make a safe kidney transplant possible.
• For one group (Cohort 1): A living kidney donor has already been identified, and blood tests show the person's immune system has developed specific proteins (antibodies) that would likely attack a donor kidney, confirmed by specialised laboratory testing within 30 days of screening.
• For another group (Cohort 2): Blood tests show that more than 80% of the population would be incompatible as donors due to the person's immune response, and at least one antibody has been identified that would make transplant unsafe.
• Detailed tissue-matching (HLA typing) for both the recipient and donor has been completed within the past 2 years.
• The person is currently considered eligible for a transplant by their local medical team, assuming a suitable kidney becomes available after treatment.
• Blood test results showing the blood is healthy enough to participate, including: haemoglobin of at least 8 g/dL, a sufficient level of white blood cells (neutrophils and lymphocytes or T-cells), and a platelet count of at least 75,000/μL.
• Vaccinations are up to date in line with national and local guidelines for transplant patients.
• A blood test shows the person has previously been exposed to the Epstein-Barr virus (a common virus, also known as glandular fever).
• A test for latent (inactive) tuberculosis (TB) has come back negative within 3 months before screening, OR any latent TB infection found has already been fully treated before the transplant.
• The person is willing and able to stay in hospital for at least 2 weeks after receiving the study treatment, and to live within 2 hours of the hospital for a further 2 weeks after being discharged.
• The person is willing and able to give informed consent and follow all study requirements.
• Contraception requirements must be met in line with local guidelines. For men who are sexually active with a partner who could become pregnant: highly effective contraception must be used for at least 3 years after receiving the study treatment, and the person must not attempt to father a child or donate sperm during that time (the partner must also use highly effective contraception for the same period). A shorter contraception period applies if the person receives only part of the study treatment (confirm with trial site).
• For women who could become pregnant and are sexually active with a male partner who has not been sterilised: highly effective contraception must be used for at least 3 years after receiving the study treatment, and a negative pregnancy blood test must be confirmed 3 days before enrolling. The person must not donate eggs within 3 years of receiving the study treatment. A shorter contraception period may apply in certain circumstances (confirm with trial site).

Who may not be able to join:

• People who have previously received a transplant of any solid organ other than a kidney, or a bone marrow transplant.
• People whose kidney failure was caused by specific kidney diseases, including complement 3 glomerulopathy, immune-complex mediated membranoproliferative glomerulonephritis, or focal and segmental glomerulosclerosis.
• People with severe circulation problems in the legs or feet, such as pain at rest or wounds that will not heal.
• People with a history of recurring urinary tract infections — specifically 2 or more in 6 months, or 3 or more in one year.
• People with a currently active serious infection (bacterial, viral, or fungal), or anyone who needed hospital treatment or intravenous antibiotics for an infection within 4 weeks of screening, or oral antibiotics within 2 weeks of screening.
• People who have ever had HIV, regardless of whether it has been treated.
• People with signs of active Hepatitis B infection based on specific blood test results (some exceptions may apply — confirm with trial site).
• People with signs of active Hepatitis C infection (some exceptions may apply for people with no active virus and no liver scarring — confirm with trial site).
• People who have a currently detectable level of certain viruses (CMV, EBV, BKV, or SARS-CoV-2) in their blood, as shown by a specific type of test (PCR).
• People where the donor's and recipient's CMV (a common virus) status is incompatible — for example, where the recipient has never been exposed to CMV but the donor has.
• People with a history of serious liver disease or scarring of the liver, or abnormal liver blood test results at screening (with a limited exception for a harmless inherited condition called Gilbert's syndrome).
• People with a history of sickle cell disease or a condition called systemic amyloidosis (a disease where abnormal proteins build up in organs).
• People who require continuous blood-thinning or anti-clotting medication due to a serious ongoing condition (some stable, symptom-free conditions such as chronic atrial fibrillation may be exceptions — confirm with trial site).
• People with a serious ongoing disease that requires long-term strong immune-suppressing treatment (low-dose steroids at or below the equivalent of 10 mg/day of prednisone may be acceptable — confirm with trial site).
• People currently receiving certain immune-suppressing treatments, including higher-dose steroids, intravenous immunoglobulin, or specific medications such as CYC, mycophenolic acid, or azathioprine, within 90 days before screening.
• People who have taken a specific class of immune-suppressing drugs called calcineurin inhibitors within 14 days before screening.
• People who have received any treatment that reduces B-cells (a type of immune cell) or certain antibody-based therapies within 6 months before enrolling.
• People with significant heart problems, including: an out-of-date heart clearance assessment (older than 6 months), severe heart failure (NYHA Class III or IV), unstable chest pain (angina), a heart pumping function below 40%, a heart attack within the past 6 months, or certain implanted heart devices.
• People with significant breathing or lung problems, including a resting blood oxygen level below 92%, or lung function test results below 50% of what is expected for their age and size (tested within the past 6 months).
• People with a known serious allergy or severe reaction to the study drug (AZD0120) or any of its ingredients, including a substance called DMSO.
• People who are currently pregnant, breastfeeding, planning to become pregnant during the study, or planning to become pregnant within 3 years of receiving the study treatment.
• People who plan to father a child during the study or within 3 years of receiving the study treatment.

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