RecruitingChronic Kidney DiseasesBladder DysfunctionBladder Absence

Concomitant Renal and Urinary Bladder Allograft Transplantation

Eligible age

1–60 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

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

Sponsor: Mayo Clinic

✓ 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.

✕ 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

Rochester

Source: ClinicalTrials.gov · NCT04626167 · last updated 2026-04-23