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New treatment option for Chronic Kidney Diseases
Official title Concomitant Renal and Urinary Bladder Allograft Transplantation
ClinicalTrials.gov ID: NCT04626167
What this study is testing
- What it's testing
- The purpose of this study is to establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 60
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join if
- 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...
- Any contraindication to general anesthesia or evaluation reveals that the subject cannot safely undergo general anesthesia and post-operative...
- Any contraindication or known anaphylactic or severe systemic reaction to either human blood products or materials of bovine origin
- people with a current positive (\>=5 mm induration for high-risk people; otherwise \>=10 mm of induration) purified protein derivative (PPD) test are...
- Known history of hypersensitivity to aminoglycosides or fluoroquinolones
- Use of any investigational product within 3 months
See the full eligibility criteria
Who can 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...
- 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...
- 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.
- 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...
- Agree to avoid pregnancy for 1 year after surgery through abstinence or approved contraception as noted in Appendix A (female people 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.
What rules you out
- 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...
- 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...
- Any contraindication or known anaphylactic or severe systemic reaction to either human blood products or materials of bovine origin
- people with a current positive (\>=5 mm induration for high-risk people; otherwise \>=10 mm of induration) purified protein derivative (PPD) test are excluded unless they have completed a full course of treatment for...
- Known history of hypersensitivity to aminoglycosides or fluoroquinolones
- Use of any investigational product within 3 months
- 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
- people with an ALT or AST value \>3 times the upper limit of normal
- people with acute or chronic abdominal skin infections and/or acute or chronic abdominal inflammatory conditions such as inflammatory bowel disease
- people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.