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CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients
Sponsor: University of Wisconsin, Madison
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.
Official title: Conversion From Immediate Release Tacrolimus to Envarsus XR® in Simultaneous Pancreas-Kidney Recipients: Assessment of Functional, Safety and Quality of Life Outcomes (CIRTEN SPK)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2019-02-27
Completion Date
2026-12
Last Updated
2025-04-25
Healthy Volunteers
No
Conditions
Interventions
Envarsus XR
The Envarsus XR® drug will be administered to study participants once daily, orally. The dosage can be 0.75 mg, 1 mg or 4 mg. The tacrolimus whole blood trough concentrations will be monitored and titrate Envarsus XR® dosage to achieve target whole blood trough concentration.
Locations (1)
University of Wisconsin
Madison, Wisconsin, United States