RecruitingEarly Phase 1NCT04626167

Concomitant Renal and Urinary Bladder Allograft Transplantation


Sponsor

Mayo Clinic

Enrollment

30 participants

Start Date

Jun 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 1 YearMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether it is safe and feasible to transplant both a kidney and a bladder at the same time for patients whose kidney disease is caused by a severely damaged or dysfunctional bladder. This is a highly specialized procedure being evaluated at Mayo Clinic. **You may be eligible if...** - You are between 1 and 60 years old - Your kidney disease is caused by a neurogenic bladder or other bladder disorder - Your bladder is considered "hostile" — meaning it stores urine at dangerously high pressures or causes kidney damage - If also needing a kidney transplant: your kidney function is very poor (GFR ≤ 20 mL/min) or you are on dialysis - You have been approved by the Mayo Clinic transplant team - You are able to learn bladder self-catheterization (or already do it) - You have no cancer history in the last 5 years (except minor skin cancer) **You may NOT be eligible if...** - You are pregnant or breastfeeding, or planning pregnancy during the study - You have certain heart, lung, liver, or kidney conditions that make surgery too risky - You have had or are at high risk for cancer - You have uncontrolled psychiatric illness or serious infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREConcomitant Renal and Urinary Bladder Allograft Transplantation

This is a single-center, prospective, single-group unblinded phase I study that will enroll subjects with chronic kidney disease secondary to bladder dysfunction or bladder absence that is refractory to medical treatment and requires surgical intervention to prevent long-term sequelae. Patients will undergo a cadaveric donor bladder transplant in addition to or after their kidney transplant rather than using intestinal segments for bladder reconstruction or contruction.


Locations(2)

Mayo Clinic

Rochester, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT04626167


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