CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients
RecruitingPhase 2/3
Conversion From Immediate Release Tacrolimus to Envarsus XR® in Simultaneous Pancreas-Kidney Recipients: Assessment of Functional, Safety and Quality of Life Outcomes (CIRTEN SPK)
Who can join
Ages 18 to 70 · All sexes
Full 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 pancreas * Uncontrolled concomitant infection at the discretion of the investigator * Presence of Donor Specific Antibodies
About the study
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.
What is being tested
- Envarsus XR (drug)
Sponsor: University of Wisconsin, Madison · Participants: 20 · Started: Feb 27, 2019
Contact the study team
- Jon S Odorico, MD · Phone: 6082639903
Official record on ClinicalTrials.gov — NCT03769298
Locations in the U.S.
| Wisconsin | University of Wisconsin, Madison |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.