CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients
Recruiting now · Phase 2/Phase 3
Conditions studied: Kidney Pancreas Transplantation
In brief
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.
Key facts
- Study ID
- NCT03769298
- Run by
- University of Wisconsin, Madison
- People needed
- 20
- Starts
- 2019-02-27
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Wisconsin — Madison, Wisconsin, United States (enrolling)
Full record on ClinicalTrials.gov
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