Recruiting

Concomitant Renal and Urinary Bladder Allograft Transplantation for Chronic Kidney Disease due to Bladder Dysfunction

Study Aim

This early phase 1 study aims to determine if concomitant renal and urinary bladder allograft transplantation is feasible for chronic kidney disease due to bladder dysfunction, focusing on the long-term function of the vascularized bladder allotransplantation in patients receiving a concomitant renal and bladder graft.

What is being tested

Concomitant Renal and Urinary Bladder Allograft Transplantation

Procedure

Who is being recruted

Congenital Abnormalities+21

+ Urogenital Diseases

+ Urinary Bladder Diseases

From 1 to 60 Years

+34 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Early Phase 1

Interventional

Study Start: June 2021

See protocol details

Summary

Principal SponsorMayo Clinic

Study ContactPatricio Gargollo, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2021

Actual date on which the first participant was enrolled.

This study focuses on individuals with chronic kidney disease caused by bladder dysfunction or absence, a condition that doesn't respond well to regular treatment and requires surgery. The main goal is to explore the feasibility of a concurrent kidney and vascularized urinary bladder transplant. This research is important as it aims to address the challenges faced by patients with bladder issues leading to kidney disease, potentially improving their quality of life and overall health. Participants who meet the study criteria will undergo a simultaneous kidney and vascularized urinary bladder transplant. The success of the procedure will be measured by bladder compliance and end filling pressure at bladder capacity, assessed through standard urodynamic measures at 12 months and yearly until year 4. The study also aims to understand the long-term function of the transplanted bladder, monitor any rejection or histological changes, and evaluate the impact of improved genitourinary function on overall health and mental health using quality of life questionnaires.

Official TitleConcomitant Renal and Urinary Bladder Allograft Transplantation

NCT04626167

Principal SponsorMayo Clinic

Study ContactPatricio Gargollo, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesUrogenital DiseasesUrinary Bladder DiseasesBladder ExstrophyUrinary Bladder Neck ObstructionUrinary Bladder, NeurogenicChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNeurologic ManifestationsPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsUrethral DiseasesUrethral ObstructionUrogenital AbnormalitiesUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

11 inclusion criteria required to participate

Patients with CKD secondary to neurogenic bladder, lower urinary tract obstruction or other disorders of the urinary bladder.

Male or female patients between 1 yr. and 60 years of age.

Subject is willing and able to give signed informed consent, or have a legally authorized representative who is willing and able to give consent. Informed assent will be required for children 6-17 years of age as appropriate or warranted.

Medical need for a bladder transplant, as defined by the presence of exhibiting "hostile bladders" defined as end filling pressure or detrusor leak point pressure (DLPP) of or greater than 40 cm H20 or at below estimated bladder capacity for age, or detrusor overactivity with detrusor sphincter dyssynergia, or new onset of upper urinary tract changes (hydronephrosis, vesicoureteral reflux) in the last 12 months

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23 exclusion criteria prevent from participating

They are pregnant or breastfeeding, or planning a pregnancy during the course of the study, or who are of child bearing potential and not willing to continue using an effective method of birth control (i.e. with a low failure rate of less than 1 percent per year including injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, or a vasectomized partner), or

Any contraindication to general anesthesia or evaluation reveals that the subject cannot safely undergo general anesthesia and post-operative recovery due to severe cardiovascular, pulmonary, neurological, metabolic, or rheumatologic disease (requires special consultation)

Any contraindication or known anaphylactic or severe systemic reaction to either human blood products or materials of bovine origin

Subjects with a current positive (>=5 mm induration for high-risk subjects; otherwise >=10 mm of induration) purified protein derivative (PPD) test are excluded unless they have completed a full course of treatment for latent TB and have a negative chest x-ray film at enrollment.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Mayo Clinic

Rochester, United StatesOpen Mayo Clinic in Google Maps

Recruiting

Mayo Clinic in Rochester

Rochester, United States

Recruiting

2 Study Centers