NCT04626167 Concomitant Renal and Urinary Bladder Allograft Transplantation

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 30 participants in total. It began in 2021-06-01 with a primary completion date of 2026-08.

Brief Summary

The purpose of this study is to establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.

Eligibility Criteria

Inclusion Criteria: * Male or female patients between 1 yr. and 60 years of age. * Subject is willing and able to give signed informed consent, or have a legally authorized representative who is willing and able to give consent. Informed assent will be required for children 6-17 years of age as appropriate or warranted. * Patients with CKD secondary to neurogenic bladder, lower urinary tract obstruction or other disorders of the urinary bladder. * Medical need for a bladder transplant, as defined by the presence of exhibiting "hostile bladders" defined as end filling pressure or detrusor leak point pressure (DLPP) of or greater than 40 cm H20 or at below estimated bladder capacity for age, or detrusor overactivity with detrusor sphincter dyssynergia, or new onset of upper urinary tract changes (hydronephrosis, vesicoureteral reflux) in the last 12 months * If a concomitant kidney transplant is being considered, additionally, estimated GFR less than or equal to 20 mL/min or dialysis. If GFR 20-25 mL/min would also qualify if expected progression is rapid (\>10 mL/min/year) * Vetting and approval by the Mayo Clinic multidisciplinary transplant team (MDC) for renal transplantation. * Ability of subject and/or care provider to be successfully trained in clean intermittent catheterization and bladder cycling. Or current use of CIC. * Utilization of maximally-tolerated dose and regimen of medical therapy (e.g. anticholinergics) or failure to tolerate/contraindications to such agents. * Psychosocial clearance: Demonstrated commitment to psychological evaluation perioperatively, in which the psychologist must confirm that the subject has the maturity and stable psychosocial environment necessary for this research study. * Agree to avoid pregnancy for 1 year after surgery through abstinence or approved contraception as noted in Appendix A (female subjects only) * If patient has a history of malignancy (with the exception of localized non-melanoma skin cancer) the patient must be at least 5 years from termination of treatment without evidence of recurrent disease. Exclusion Criteria: * They are pregnant or breastfeeding, or planning a pregnancy during the course of the study, or who are of child bearing potential and not willing to continue using an effective method of birth control (i.e. with a low failure rate of less than 1 percent per year including injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, or a vasectomized partner), or * Any contraindication to general anesthesia or evaluation reveals that the subject cannot safely undergo general anesthesia and post-operative recovery due to severe cardiovascular, pulmonary, neurological, metabolic, or rheumatologic disease (requires special consultation) * Any contraindication or known anaphylactic or severe systemic reaction to either human blood products or materials of bovine origin * Subjects with a current positive (\>=5 mm induration for high-risk subjects; otherwise \>=10 mm of induration) purified protein derivative (PPD) test are excluded unless they have completed a full course of treatment for latent TB and have a negative chest x-ray film at enrollment. * Known history of hypersensitivity to aminoglycosides or fluoroquinolones * Use of any investigational product within 3 months * Prior participation in the study * Currently smoking * Current incarceration for any reason * Unwillingness, inability, or unlikely compliance of individual and/or primary caregiver with study related schedules procedures, management, or follow -up in the opinion of the PI and/or co-investigators * Any circumstance in which the investigator deems participation in the study is not in the subject's best interest * Subjects with an ALT or AST value \>3 times the upper limit of normal * Subjects with acute or chronic abdominal skin infections and/or acute or chronic abdominal inflammatory conditions such as inflammatory bowel disease * Subjects with uncontrolled diabetes defined as HgA1c\>10, unstable cardiac and/or pulmonary disorders, or bleeding disorders * Active malignant neoplasm (with the exception of localized non-melanoma skin cancer) that is untreated, unresponsive to available treatment, or too recently treated to determine relapse risk. * Surgical procedure for transplantation cannot be successfully performed for anatomical reasons * Life expectancy with successful transplantation is estimated to be \<5 years for any reason. * There is any other disease, physical examination finding, or clinical laboratory result that provides a reasonable suspicion of a disease or condition that contraindicates the procedure or the interpretation of results or render the subject at high risk for treatment complications, or * Serious or uncontrolled psychiatric illness or disorder that could compromise their understanding of, or compliance with, follow-up visits/care after transplant, or * Taking medications on specified hourly intervals that may be affected by changes to renal clearance, or * Hypertension stage II \> 99th percentile, unless they had a complete workup to exclude secondary etiologies other than being overweight, or * Presence of severe coagulopathy, (hyper or hypo) * Patient is not up to date on current CDC recommended vaccines

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