RecruitingPhase 2Phase 3NCT03769298

CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients

Conversion From Immediate Release Tacrolimus to Envarsus XR® in Simultaneous Pancreas-Kidney Recipients: Assessment of Functional, Safety and Quality of Life Outcomes (CIRTEN SPK)

Sponsor

University of Wisconsin, Madison

Enrollment

20 participants

Start Date

Feb 27, 2019

Study Type

INTERVENTIONAL

Conditions

Kidney Pancreas Transplantation

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Envarsus XR for people with kidney pancreas transplantation. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnvarsus 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

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NCT03769298