Status:
RECRUITING
CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Veloxis Pharmaceuticals
Conditions:
Kidney Pancreas Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a Phase II/III, Single-center, Prospective, Open-label, Single Arm Study of 20 Simultaneous Kidney Pancreas recipients who received a transplant at least 3 months, but no more than 5 years pri...
Detailed Description
Accrual objective: Enrollment of 2-3 participants per month and all participants within an 18 month period. With minimum of 1 year follow-up post-conversion, we anticipate the entire study would be co...
Eligibility Criteria
Inclusion
- Adult, 18-70 years of age
- Participant must be able to understand and provide consent
- History of Diabetes Type 1 or Insulin-Dependent Diabetes Type 2 with Chronic Kidney Disease (CKD)
- Recipient of a Simultaneous Pancreas Kidney (SPK) transplant, 3- 60 months prior to screening, per Principal Investigator's discretion.
- Have a history of tremors following transplantation
- Stable pancreas allograft function as evidenced by no requirement of exogenous insulin or oral anti-diabetic agents and stable pancreatic enzymes
- Stable kidney allograft function
- Currently taking Immediate-Release (IR) tacrolimus
- Women of child-bearing potential (WOCP) must have a negative pregnancy test at the time of study entry
Exclusion
- Currently maintained on an extended-release tacrolimus immunosuppressive regimen
- Previous history of tremors prior to transplantation
- Solitary pancreas transplant recipients
- History of solid organ transplant other than a kidney or pancreas
- Uncontrolled concomitant infection at the discretion of the investigator
- Presence of Donor Specific Antibodies
Key Trial Info
Start Date :
February 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03769298
Start Date
February 27 2019
End Date
December 1 2026
Last Update
April 25 2025
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53792