Concomitant Renal and Urinary Bladder Allograft Transplantation for Chronic Kidney Disease

This study is looking at a new surgical procedure called Concomitant Renal and Urinary Bladder Allograft Transplantation. This procedure involves transplanting both a kidney and a bladder at the same time. It's for people aged 1 to 60 years old who have long-term kidney disease because their bladder doesn't work well or is missing, and other treatments haven't helped. The main goal is to see if this combined transplant is possible and how well the transplanted bladder works over 1 to 4 years. This is a small, early-stage study with a planned enrollment of 30 participants. The study status is currently unclear.

Study design: This is an early-stage (Phase I) study, meaning it's one of the first times this procedure is being tested in people. It's a single-group study, so all 30 participants will receive the Concomitant Renal and Urinary Bladder Allograft Transplantation.
What's involved: If you meet the study criteria, you would undergo baseline evaluations and then the Concomitant Renal and Urinary Bladder Allograft Transplantation. The study will then follow your progress for 1 to 4 years.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 1 to 4 years after the transplant to see how well the new kidney and bladder are working.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Concomitant Renal and Urinary Bladder Allograft Transplantation

Recruiting

EARLY_PHASE1Ages 1–60InterventionalTreatment

Mayo Clinic

~30 participants

Updated 2026-04-23 on ClinicalTrials.gov

What's tested:Concomitant Renal and Urinary Bladder Allograft Transplantation

At a glance

Recruiting sites

2 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.

Measured over Year 1-4

+1 more outcome measured

Conditions

Chronic Kidney Diseases

Bladder Dysfunction

Bladder Absence

Posterior Urethral Valve

Neurogenic Bladder

Bladder Exstrophy

Bladder Outlet Obstruction

Failure, Kidney

Transplant

NCT04626167

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Mayo Clinic
Rochester, Minnesotastudy coordinator listed
Recruiting
Mayo Clinic in Rochester
Rochester, Minnesotano site contact published
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Patricio Gargollo, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Vidhu Joshi

[email protected]

(507) 538-5772

Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

Establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.Year 1-4
The primary endpoint will be bladder compliance and/or the end fill pressure at bladder capacity as assessed by standardized urodynamic measures at 12 months and yearly until year 4 Urodynamic measures assessed multiple times in each subject over the follow up period will be modeled with linear mixed effects models. A discrete time relationship will estimate the mean bladder compliance or end fill pressure at 12 months and yearly until year 4. Models will adjust for baseline value, and random intercepts and slopes will be considered using model fit criteria. From this linear mixed effects model, we estimate the expected change from baseline to 12 months (and yearly until year 4), adjusting for baseline value. Results will be reported as estimated 12 month mean with confidence interval.
Study the long term function of vascularized bladder allotransplantation in patients receiving a concomitant renal and bladder graftYear 1-4
End-filling pressure at age-related nomogram derived bladder capacity at baseline, 6 months, 12 months, and 24 months. a. Ratio of measured bladder volume to age-related nomogram derived bladder capacity at baseline, 2,4, 6, 9, 12, and 48 months Filling pressure at 25, 33, 50, 66, and 75 percent of the age-related nomogram-derived bladder capacities Neurogenic detrusor overactivity Frequency of incontinence episodes . 3. Individual subject data including resolution of vesicoureteral reflux, hydronephrosis or recovery of renal function . 4\. Evaluating the effect of improved genitourinary function on overall health and mental health using QoL questionaires 5. Rejection and other histological changes will be monitored with protocol biopsies at month 2, 4, 12, 24, 48 and annually until year 4. For cause biopsies for clinical changes such as decreased compliance or hematuria will also be performed.

Trialytics