NCT03769298 CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients
| NCT ID | NCT03769298 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University of Wisconsin, Madison |
| Condition | Kidney Pancreas Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2019-02-27 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
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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 prior, with a history of tremors following transplantation.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
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