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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 1-4
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 1-4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 1-4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.
Urinary Bladder
Secondary outcome measures
Incidence of all serious adverse events including unanticipated adverse events
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.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,766,830 Total Patients Enrolled
Patricio Gargollo, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a current positive TB skin test or have completed treatment for latent TB with a negative chest x-ray.I can sign the consent form myself, or have someone legally allowed to do it for me.My kidney function is very low, possibly needing a transplant.You have a severe blood clotting problem, whether it's too much or too little clotting.Your liver enzymes (ALT or AST) are more than three times the normal limit.Doctors think you may not live more than 5 years after the transplant for any reason.I am between 1 and 60 years old.I have an ongoing skin infection or inflammation in my belly area.I have used the highest dose of my medication that I can tolerate without success.I take medications that could be affected by how my kidneys work.I or my caregiver can learn or already know how to use a catheter.My kidney disease is due to a bladder condition.I do not have uncontrolled diabetes, unstable heart/lung conditions, or bleeding disorders.You are currently a smoker.I need a bladder transplant due to severe bladder issues.I had cancer before, but it's been 5 years since my treatment ended with no signs of it coming back.I do not have any health conditions that would make the treatment risky for me.I have cancer that is untreated, not responding to treatment, or too soon after treatment to know if it's back.I am not pregnant, breastfeeding, or planning to become pregnant, and I use effective birth control.You have a severe allergic reaction to human blood products or materials from cows.I cannot have a transplant surgery due to anatomical reasons.You have very high blood pressure, unless it's been checked to make sure there's no other reason for it besides being overweight.You have had a bad reaction to aminoglycosides or fluoroquinolones in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects are being monitored for this medical experiment?
"Confirmed, the clinical trial is still recruiting patients. This medical experiment was initially launched on June 1st 2021, and its details have been most recently updated on June 23rd 2022. The study seeks to enrol 30 individuals at 2 separate sites."
Answered by AI
Are there any available slots for potential participants of this experiment?
"As per the clinicaltrials.gov entry, this trial is still seeking participants; its inception date was June 1st 2021 and it was revised on June 23rd 2022."
Answered by AI
Could I be considered to partake in this medical study?
"This clinical trial seeks thirty individuals aged between one and sixty who have bladder exstrophy. Eligible participants must be able to adhere to clean intermittent catheterization (CIC) and bladder cycling, take optimal doses of anticholinergic drugs or display contraindications for such agents, present with CKD due to neurogenic bladders, lower urinary tract obstruction or other disorders of the urinary bladder, demonstrate a medical need for a transplant as evidenced by hostile bladders defined as end filling pressure or detrusor leak point pressure (DLPP) of greater than 40 cm H20 below estimated capacity for age; new onset of upper"
Answered by AI
Is there an age cutoff for eligibility in this trial?
"As per the entry requirements for this clinical research, enrollees must be at least 1 year old and not exceed 60 years of age."
Answered by AI
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