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:

• People between 1 and 60 years of age (male or female).
• People who are willing and able to give signed agreement to take part, or who have a legally authorised representative who can do so on their behalf. Children aged 6–17 may also be asked to give their own agreement where appropriate.
• People whose chronic kidney disease is caused by a bladder that does not work properly due to nerve problems, a blockage in the lower urinary tract, or other bladder conditions.
• People whose bladder is considered "hostile" — meaning pressure inside the bladder is dangerously high, the bladder fills to less than the expected amount for their age, or there are signs of abnormal bladder muscle activity, or new changes in the upper urinary tract (such as kidney swelling or urine flowing back toward the kidneys) that have appeared in the last 12 months.
• People being considered for a kidney transplant at the same time, where kidney function has declined significantly or kidney function is declining rapidly (confirm with trial site for exact measurements).
• People who have been reviewed and approved for a kidney transplant by the Mayo Clinic's specialist transplant team.
• People (or their carers) who are able to be trained in, or are already using, a bladder-emptying technique called clean intermittent catheterisation (CIC).
• People who have already tried the highest tolerated dose of relevant medications (such as bladder-calming medicines), or who are unable to take those medications due to side effects or medical reasons.
• People who have completed a psychological evaluation confirming they have the emotional maturity and stable personal circumstances needed for this research study.
• Female participants who agree to avoid pregnancy for one year after surgery, either through abstinence or an approved method of contraception.
• People with a history of cancer (except certain minor skin cancers) who have been free of treatment and show no signs of the cancer returning for at least 5 years.

Who may not be able to join:

• People who are pregnant, breastfeeding, planning a pregnancy during the study, or who are able to become pregnant and are not willing to use an effective form of contraception.
• People for whom general anaesthesia would not be safe, due to serious heart, lung, neurological, metabolic, or rheumatological conditions (specialist review required).
• People who have a known severe allergic reaction to human blood products or materials derived from cattle.
• People with a positive tuberculosis (TB) skin test result, unless they have already completed a full course of treatment for inactive TB and have a clear chest X-ray at the time of enrolment.
• People with a known allergy to certain types of antibiotics (aminoglycosides or fluoroquinolones).
• People who have taken part in another clinical trial within the past 3 months.
• People who have previously participated in this specific study.
• People who are currently smoking.
• People who are currently incarcerated for any reason.
• People (or their primary carers) who are considered unlikely or unable to follow the study's schedules, procedures, or follow-up requirements, in the opinion of the research team.
• People where the research team considers that taking part would not be in their best interest.
• People with significantly elevated liver enzyme levels (ALT or AST more than 3 times the normal upper limit).
• People with active skin infections on the abdomen, or ongoing abdominal inflammatory conditions such as inflammatory bowel disease.
• People with poorly controlled diabetes, unstable heart or lung conditions, or bleeding disorders.
• People with an active cancer (except certain minor skin cancers) that is untreated, not responding to treatment, or too recently treated to know if it has returned.
• People whose body structure means the transplant surgery cannot be performed safely.
• People whose life expectancy after a successful transplant is estimated to be less than 5 years for any reason.
• People with any other medical finding or condition that would make the procedure unsafe or make results difficult to interpret.
• People with a serious or uncontrolled mental health condition that could affect their ability to understand the study or attend follow-up care.
• People taking certain time-sensitive medications that could be affected by changes in how the kidneys clear drugs from the body.
• People with significantly high blood pressure (Stage II, above the 99th percentile), unless a full investigation has been completed to rule out causes other than being overweight.
• People with a severe blood clotting disorder (either clotting too much or too little).
• People who are not up to date with the vaccines currently recommended by the CDC.

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