Double transplant: kidney and bladder together for the first time
NCT ID NCT04626167
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial at Mayo Clinic is testing whether it is possible to transplant a bladder along with a kidney in people who have kidney failure due to bladder problems. Up to 30 participants will receive both organs from a deceased donor. The goal is to see if the bladder works well and safely over time, avoiding the need for bowel tissue to rebuild the bladder.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bladder and kidney transplant surgery
- What this could lead to
- If successful, this could offer a new option for people needing both a kidney and a working bladder, potentially avoiding the need for bowel segments in bladder reconstruction.
- What could go wrong
- This is a very early phase 1 trial with only 30 participants, so it is not yet proven safe or effective. There are risks from major surgery, organ rejection, and lifelong immunosuppression.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2021
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55901, United States
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Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
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