Concomitant Renal and Urinary Bladder Allograft Transplantation

Chronic Kidney Diseases Clinical Trial

Official title: Concomitant Renal and Urinary Bladder Allograft Transplantation

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04626167
• Study type: Interventional
• Source: Mayo Clinic
• Contact: Vidhu Joshi
• Phone: (507) 538-5772
• Email: Kroeninger.Tessa@mayo.edu
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 1, 2021
• Completion date: January 2026