Concomitant Renal and Urinary Bladder Allograft Transplantation

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT04626167
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
1 Year - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Concomitant Renal and Urinary Bladder Allograft Transplantation — PROCEDURE
    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.

Study Details

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

Key Dates

Start date
Jun 1, 2021
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention group
    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 construction.

Primary Outcome Measure

Establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible. [ Time Frame: Year 1-4 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55901
Tessa Kroeninger
[email protected]
(507)538-6107
Mayo Clinic in RochesterRochesterMinnesota55905-

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