Status:

COMPLETED

CNS Study of Patients Switching From Tacrolimus to Envarsus

Lead Sponsor:

University of Colorado, Denver

Conditions:

Renal Transplant Patients

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

This is a pilot study documenting the neurotoxic side effects including tremors in patients with a stable graft who are receiving Tacrolimus following kidney transplantation. A standardized questionna...

Detailed Description

Immunosuppressive therapies have burdensome side effects which may lead to sub-therapeutic dosing and non-compliance. This study provides renal transplant patients the opportunity for an alternative ...

Eligibility Criteria

Inclusion

  • Kidney transplant recipients with stable graft function.
  • More than 1 months post-transplant.
  • 18+ years of age with some CNS problems secondary to Prograf (tacrolimus).

Exclusion

  • Multi-organ patients (kidney/pancreas, kidney/liver).
  • Evidence of graft rejection or treatment of acute rejection within 14 days prior to baseline visit.
  • Inability to self-administer the QOL questionnaires.

Key Trial Info

Start Date :

December 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 2 2020

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT03270462

Start Date

December 1 2017

End Date

June 2 2020

Last Update

June 2 2022

Active Locations (1)

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1

Lisa Kornfeld

Aurora, Colorado, United States, 80045