Concomitant Renal and Urinary Bladder Allograft Transplantation
NCT04626167 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-04-23
Summary
The purpose of this study is to establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.
Conditions
- Chronic Kidney Diseases
- Bladder Dysfunction
- Bladder Absence
- Posterior Urethral Valve
- Neurogenic Bladder
- Bladder Exstrophy
- Bladder Outlet Obstruction
- Failure, Kidney
- Transplant
Interventions
- 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.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Patricio Gargollo, MD · Mayo Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-01
- Primary Completion
- 2026-08-31
- Completion
- 2026-08-31
Countries
- United States
Study Locations
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