Concomitant Renal and Urinary Bladder Allograft Transplantation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bladder Absence
- Bladder Dysfunction
- Bladder Exstrophy
- Bladder Outlet Obstruction
- Chronic Kidney Diseases
- Failure, Kidney
- Neurogenic Bladder
- Posterior Urethral Valve
- Transplant
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 1 years and 60 years
- Gender
- Both males and females
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 i...
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.
Tracking Information
- NCT #
- NCT04626167
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Patricio Gargollo, MD Mayo Clinic