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RECRUITING
NCT03769298
PHASE2/PHASE3

CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients

Sponsor: University of Wisconsin, Madison

View on ClinicalTrials.gov

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

Interventions

DRUG

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