Chronic Kidney DiseasesEarly Phase 1NCT04626167
Concomitant Renal and Urinary Bladder Allograft Transplantation
A Early Phase 1 study testing Concomitant Renal and Urinary Bladder Allograft Transplantation in people with Chronic Kidney Diseases and Bladder Dysfunction, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this study is to establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible. Read more about this study
- Who is it for?
- Ages 1 year to 60 years
- Conditions the study is for
- Chronic Kidney Diseases, Bladder Dysfunction, Bladder Absence
- What is being tested?
- Concomitant Renal and Urinary Bladder Allograft Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2021to Sep 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- Patients with CKD secondary to neurogenic bladder, lower urinary tract obstruction or other disorders of the urinary bladder.
- 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
- If a concomitant kidney transplant is being considered, additionally, estimated GFR less than or equal to 20 mL/min or dialysis. If GFR 20-25 mL/min would also qualify if expected progression is rapid (>10 mL/min/year)
- Vetting and approval by the Mayo Clinic multidisciplinary transplant team (MDC) for renal transplantation.
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- Ability of subject and/or care provider to be successfully trained in clean intermittent catheterization and bladder cycling. Or current use of CIC.
- Utilization of maximally-tolerated dose and regimen of medical therapy (e.g. anticholinergics) or failure to tolerate/contraindications to such agents.
- Psychosocial clearance: Demonstrated commitment to psychological evaluation perioperatively, in which the psychologist must confirm that the subject has the maturity and stable psychosocial environment necessary for this research study.
- Agree to avoid pregnancy for 1 year after surgery through abstinence or approved contraception as noted in Appendix A (female subjects only)
- If patient has a history of malignancy (with the exception of localized non-melanoma skin cancer) the patient must be at least 5 years from termination of treatment without evidence of recurrent disease.
Who cannot join
- 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.
- Known history of hypersensitivity to aminoglycosides or fluoroquinolones
- Use of any investigational product within 3 months
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- Prior participation in the study
- Currently smoking
- Current incarceration for any reason
- Unwillingness, inability, or unlikely compliance of individual and/or primary caregiver with study related schedules procedures, management, or follow -up in the opinion of the PI and/or co-investigators
- Any circumstance in which the investigator deems participation in the study is not in the subject's best interest
- Subjects with an ALT or AST value >3 times the upper limit of normal
- 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
- Active malignant neoplasm (with the exception of localized non-melanoma skin cancer) that is untreated, unresponsive to available treatment, or too recently treated to determine relapse risk.
- Surgical procedure for transplantation cannot be successfully performed for anatomical reasons
- Life expectancy with successful transplantation is estimated to be <5 years for any reason.
- There is any other disease, physical examination finding, or clinical laboratory result that provides a reasonable suspicion of a disease or condition that contraindicates the procedure or the interpretation of results or render the subject at high risk for treatment complications, or
- Serious or uncontrolled psychiatric illness or disorder that could compromise their understanding of, or compliance with, follow-up visits/care after transplant, or
- Taking medications on specified hourly intervals that may be affected by changes to renal clearance, or
- Hypertension stage II > 99th percentile, unless they had a complete workup to exclude secondary etiologies other than being overweight, or
- Presence of severe coagulopathy, (hyper or hypo)
- Patient is not up to date on current CDC recommended vaccines
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Patricio Gargollo, MD contact
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55901
Tessa Kroeninger, (507)538-6107, Kroeninger.Tessa@mayo.edu
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The purpose of this study is to establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.
Read the 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.
- Conditions
- Chronic Kidney Diseases, Bladder Dysfunction, Bladder Absence, Posterior Urethral Valve, Neurogenic Bladder, Bladder Exstrophy
- Being tested
- Concomitant Renal and Urinary Bladder Allograft Transplantation
- Keywords
- Urinary Bladder Transplant, Bladder Transplant, Bladder Augment, Neobladder, Ileocystoplasty
- Medical subject headings
- Renal Insufficiency, Chronic, Urinary Bladder, Neurogenic, Bladder Exstrophy, Urinary Bladder Neck Obstruction, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concomitant Renal and Urinary Bladder Allograft TransplantationProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Intervention group | 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. Receives: Procedure: Concomitant Renal and Urinary Bladder Allograft Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.
The primary endpoint will be bladder compliance and/or the end fill pressure at bladder capacity as assessed by standardized urodynamic measures at 12 months and yearly until year 4 Urodynamic measures assessed multiple times in each subject over the follow up period will be modeled with linear mixed effects models. A discrete time relationship will estimate the mean bladder compliance or end fill pressure at 12 months and yearly until year 4. Models will adjust for baseline value, and random intercepts and slopes will be considered using model fit criteria. From this linear mixed effects model, we estimate the expected change from baseline to 12 months (and yearly until year 4), adjusting for baseline value. Results will be reported as estimated 12 month mean with confidence interval.
Measured: Year 1-4
Study the long term function of vascularized bladder allotransplantation in patients receiving a concomitant renal and bladder graft
End-filling pressure at age-related nomogram derived bladder capacity at baseline, 6 months, 12 months, and 24 months.
- Ratio of measured bladder volume to age-related nomogram derived bladder capacity at baseline, 2,4, 6, 9, 12, and 48 months Filling pressure at 25, 33, 50, 66, and 75 percent of the age-related nomogram-derived bladder capacities Neurogenic detrusor overactivity Frequency of incontinence episodes . 3. Individual subject data including resolution of vesicoureteral reflux, hydronephrosis or recovery of renal function .
- Evaluating the effect of improved genitourinary function on overall health and mental health using QoL questionaires 5. Rejection and other histological changes will be monitored with protocol biopsies at month 2, 4, 12, 24, 48 and annually until year 4. For cause biopsies for clinical changes such as decreased compliance or hematuria will also be performed.
Measured: Year 1-4
Secondary outcomes (1)
Incidence of all serious adverse events including unanticipated adverse events
All adverse events will be captured and graded for severity using Common Terminology Criteria for Adverse Events (CTCAE) scale.
Measured: Year 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start1 Jun 2021
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricio C. Gargollo, Mayo Clinic
- Investigators
- Patricio Gargollo, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626167
- Sponsor's protocol ID
- 18-004920
- Other IDs
- W81XWH2010662
- Status last verified
- Sep 2026
- First submitted
- 13 Oct 2020
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Renal and Urinary Bladder Allograft Transplantation
- ClinicalTrials.gov ID
- NCT04626167
- Acronym / sponsor ID
- 18-004920
- Conditions
- Chronic Kidney Diseases, Bladder Dysfunction, Bladder Absence, Posterior Urethral Valve, Neurogenic Bladder, Bladder Exstrophy
- Keywords
- Urinary Bladder Transplant, Bladder Transplant, Bladder Augment, Neobladder, Ileocystoplasty
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Concomitant Renal and Urinary Bladder Allograft TransplantationPatients 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. |
Who may qualify
- Ages
- 1 year to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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.
- Patients with CKD secondary to neurogenic bladder, lower urinary tract obstruction or other disorders of the urinary bladder.
- 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
- If a concomitant kidney transplant is being considered, additionally, estimated GFR less than or equal to 20 mL/min or dialysis. If GFR 20-25 mL/min would also qualify if expected progression is rapid (>10 mL/min/year)
Key exclusion criteria (23 listed)
- 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.
- Known history of hypersensitivity to aminoglycosides or fluoroquinolones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concomitant Renal and Urinary Bladder Allograft TransplantationThis 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. | Procedure or surgery | Intervention group |
Primary outcome
Establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.
Time frame: Year 1-4
The primary endpoint will be bladder compliance and/or the end fill pressure at bladder capacity as assessed by standardized urodynamic measures at 12 months and yearly until year 4 Urodynamic measures assessed multiple times in each subject over the follow up period will be modeled with linear mixed effects models. A discrete time relationship will estimate the mean bladder compliance or end fill pressure at 12 months and yearly until year 4. Models will adjust for baseline value, and random intercepts and slopes will be considered using model fit criteria. From this linear mixed effects model, we estimate the expected change from baseline to 12 months (and yearly until year 4), adjusting for baseline value. Results will be reported as estimated 12 month mean with confidence interval.
Study the long term function of vascularized bladder allotransplantation in patients receiving a concomitant renal and bladder graft
Time frame: Year 1-4
End-filling pressure at age-related nomogram derived bladder capacity at baseline, 6 months, 12 months, and 24 months. a. Ratio of measured bladder volume to age-related nomogram derived bladder capacity at baseline, 2,4, 6, 9, 12, and 48 months Filling pressure at 25, 33, 50, 66, and 75 percent of the age-related nomogram-derived bladder capacities Neurogenic detrusor overactivity Frequency of incontinence episodes . 3. Individual subject data including resolution of vesicoureteral reflux, hydronephrosis or recovery of renal function . 4. Evaluating the effect of improved genitourinary function on overall health and mental health using QoL questionaires 5. Rejection and other histological changes will be monitored with protocol biopsies at month 2, 4, 12, 24, 48 and annually until year 4. For cause biopsies for clinical changes such as decreased compliance or hematuria will also be performed.
1 secondary outcome
Incidence of all serious adverse events including unanticipated adverse events
Time frame: Year 1-4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patricio Gargollo, MD contact
Patricio Gargollo, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Concomitant Renal and Urinary Bladder Allograft Transplantation in people with Chronic Kidney Diseases and Bladder Dysfunction, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vidhu Joshi ((507) 538-5772, Kroeninger.Tessa@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible. (time frame: Year 1-4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.