NCT04626167

Concomitant Renal and Urinary Bladder Allograft Transplantation

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 1 Year – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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. The primary inclusion criteria will be patients who are diagnosed with chronic kidney disease secondary to disorders involving the urinary bladder or absence of a urinary bladder. Patients exhibiting "hostile bladders" defined as end filling pressure or detrusor leak point pressure (DLPP) of 40 cm H2O or greater as measured by urodynamic studies or detrusor overactivity with detrusor sphincter dyssynergia will be included. Candidates for renal transplantation will be vetted and approved by the Mayo Clinic multidisciplinary transplant team (MDC). Subjects meeting these primary inclusion criteria can be referred to the PI, co-investigators, or study coordinator to approach for possible participation in this research study. If the subject still meets all the inclusion and exclusion criteria after the baseline evaluations are completed, the subject will undergo concomitant renal and vascularized urinary bladder allograft transplantation.

Conditions

• Chronic Kidney Diseases
• Bladder Dysfunction
• Bladder Absence
• Posterior Urethral Valve
• Neurogenic Bladder
• Bladder Exstrophy
• Bladder Outlet Obstruction
• Failure, Kidney
• Transplant

Interventions

Type	Name	Description
PROCEDURE	Concomitant 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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2020-11-12
• Last updated: 2025-07-16

Locations

2 sites across 1 country: United States