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Transplantation

Kidney + Bladder Transplant for Organ Failure

Phase < 1

Recruiting

Led By Patricio Gargollo, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Ability of subject and/or care provider to be successfully trained in clean intermittent catheterization and bladder cycling. Or current use of CIC

Must not have

Subjects with acute or chronic abdominal skin infections and/or acute or chronic abdominal inflammatory conditions such as inflammatory bowel disease

Subjects with uncontrolled diabetes defined as HgA1c>10, unstable cardiac and/or pulmonary disorders, or bleeding disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 1-4

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if it is possible to transplant both a kidney and bladder from another person.

Who is the study for?

This trial is for individuals aged 1-60 with severe kidney disease or bladder conditions needing both a kidney and bladder transplant. They must be able to perform self-catheterization, have stable mental health, and not be pregnant. Excluded are those with certain allergies, active infections, recent cancer treatments (except skin cancer), uncontrolled diabetes or hypertension, psychiatric issues affecting compliance, or any condition making surgery too risky.

What is being tested?

The study tests the feasibility of performing simultaneous kidney and vascularized urinary bladder transplants in patients who need them due to severe organ dysfunction. It aims to determine if this combined procedure can be done safely and effectively.

What are the potential side effects?

Potential side effects may include typical risks associated with transplant surgeries such as infection risk from immunosuppressive drugs required post-transplantation, surgical complications like bleeding or clotting issues, anesthesia reactions, and possible organ rejection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 1 and 60 years old.

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I or my caregiver can learn or already know how to use a catheter.

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My kidney disease is due to a bladder condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an ongoing skin infection or inflammation in my belly area.

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I do not have uncontrolled diabetes, unstable heart/lung conditions, or bleeding disorders.

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I cannot have a transplant surgery due to anatomical reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 1-4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 1-4

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 1-4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.

Urinary Bladder

Secondary study objectives

Incidence of all serious adverse events including unanticipated adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention groupExperimental Treatment1 Intervention

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.

0 / 6Eligibility criteria met