A Study to Evaluate the Safety and Effectiveness of Once-Daily Envarsus XR® and Twice-Daily, Immediate-Release Tacrolimus in Adult Renal Transplant Recipients

Overview

Información sobre este estudio

The purpose of this study is to compare tacrolimus formulations (Envarsus XR® versus twice a day tacrolimus) with the hypothesis that Envarsus XR® improves transplant- and tacrolimus- associated symptoms when compared to a twice a day tacrolimus regimen.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

  • Patient is an adult (18 years of age or older).
  • Treatment with Envarsus XR® or immediate-release, twice-daily tacrolimus has been indicated by patient’s transplant care team. 
  • Patient is a recipient of a deceased or living donor kidney transplant.
  • Patient is able to comply with study procedures for the entire length of the study.
  • Patient has been informed about the study survey and has signed an informed consent form.

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Patient is unable or unwilling to complete study patient reported outcome questionnaires.
  • Patient is currently receiving azathioprine
  • Patient is currently receiving an mTOR inhibitor (sirolimus, everolimus)
  • Patient is currently receiving belatacept .
  • Patient has received investigational immunosuppression 1 month prior to transplant or post-transplant.
  • Patient is in a setting where a professional care taker is responsible for dispensing subject’s medication.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Mark Stegall, M.D.

Cerrado para la inscripción

Contact information:

Nong Yowe Braaten L.P.N.

Braaten.Nong@mayo.edu

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Martin Mai, M.D.

Cerrado para la inscripción

Contact information:

Joel Espinoza

Espinoza.Joel@mayo.edu

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Sumi Nair, M.B.B.S., M.D.

Cerrado para la inscripción

Contact information:

Angela Eyshou M.B.A.

(480) 342-6536

Eyshou.Angela@mayo.edu

More information

Publicaciones

Publications are currently not available
.
CLS-20491456

Mayo Clinic Footer