Actively Recruiting
Concomitant Renal and Urinary Bladder Allograft Transplantation to Evaluate Feasibility and Long-Term Function
Led by Mayo Clinic · Updated on 2026-04-23
30
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether it is possible to perform kidney and bladder transplants together in patients who have chronic kidney disease caused by bladder problems or absence of a bladder. This early-phase, single-center study focuses on patients whose bladder issues have not improved with medical treatment and who need surgery to avoid long-term complications. The study includes patients with "hostile bladders," defined by specific bladder pressure measurements or bladder muscle disorders, and candidates must be approved by a transplant team. Participants will receive a transplant of a cadaveric donor bladder either at the same time as or after their kidney transplant, instead of the usual method of using intestinal segments for bladder reconstruction. This is a single-group study where all patients receive this combined transplant procedure. The research aims to evaluate the feasibility of this approach and study the long-term function of the transplanted bladder. During the study, participants will be closely monitored for how well the transplanted organs work and for any serious side effects over the course of up to four years. The medical team will conduct evaluations including urinary function assessments and follow-up visits to understand the outcomes and safety of the combined transplant. The total study period includes careful long-term observation to assess the success and any risks associated with the procedure.
CONDITIONS
Brief Title
Concomitant Renal and Urinary Bladder Allograft Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients between 1 yr. and 60 years of age.
- Willing and able to give signed informed consent or have a legally authorized representative who can.
- Diagnosed with chronic kidney disease secondary to neurogenic bladder, lower urinary tract obstruction, or other bladder disorders.
- Medical need for bladder transplant due to hostile bladder conditions such as high bladder pressure or detrusor overactivity.
- If kidney transplant is considered, estimated GFR ≤20 mL/min or dialysis, or GFR 20-25 mL/min with rapid progression.
- Approved by the Mayo Clinic multidisciplinary transplant team for renal transplantation.
- Ability to be trained in clean intermittent catheterization or current use of it.
- Have tried maximally tolerated medical therapy or have contraindications to such treatments.
- Psychosocial clearance confirming maturity and stable environment.
- Agree to avoid pregnancy for 1 year after surgery (female subjects).
- If history of cancer (except localized non-melanoma skin cancer), must be at least 5 years disease-free.
You will not qualify if you...
- Pregnant, breastfeeding, planning pregnancy during the study, or not willing to use effective birth control (female subjects).
- Contraindications to general anesthesia or unsafe for surgery due to severe medical conditions.
- Known severe allergic reactions to blood products or bovine materials.
- Positive tuberculosis test unless fully treated with negative chest x-ray.
- Known allergy to aminoglycosides or fluoroquinolones.
- Use of investigational products within 3 months.
- Prior participation in this study.
- Current smoking.
- Current incarceration.
- Unwillingness or inability to comply with study procedures.
- Any condition making participation unsafe or not in the subject's best interest.
- Elevated liver enzymes above 3 times normal.
- Abdominal infections or inflammatory bowel disease.
- Uncontrolled diabetes, unstable cardiac/pulmonary disorders, or bleeding disorders.
- Active malignant cancer except localized non-melanoma skin cancer.
- Anatomical reasons preventing transplant surgery.
- Life expectancy less than 5 years despite transplant.
- Serious psychiatric illness affecting compliance.
- Medications affected by renal clearance changes on specified schedules.
- Severe hypertension unless secondary causes excluded.
- Severe blood clotting disorders.
- Not up to date on CDC recommended vaccines.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Varies per participant until discharge
Participants undergo concomitant renal and urinary bladder allograft transplantation surgery followed by immediate post-operative care.
1 surgical procedure and hospitalization period
Duration - Up to 4 years
Participants are monitored for long-term function of the transplanted bladder and kidney and for any serious adverse events.
Regular follow-up visits throughout the study duration
Trial Site Locations
Total: 2 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55901
Actively Recruiting
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
V
Vidhu Joshi
P
Patricio Gargollo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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