Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-28 @ 7:38 PM
Study NCT ID:
NCT04626167
Status:
RECRUITING
Last Update Posted:
2025-07-16
First Post:
2020-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concomitant Renal and Urinary Bladder Allograft Transplantation
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Concomitant Renal and Urinary Bladder Allograft Transplantation
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| W81XWH2010662 | OTHER_GRANT | Department of Defense | View |