CNS Study of Patients Switching From Tacrolimus to Envarsus

University of Colorado Denver (CU Denver)

Status and phase

Completed

Phase 4

Conditions

Renal Transplant Patients

Treatments

Drug: Envarsus XR

Study type

Interventional

Funder types

Other

Identifiers

NCT03270462

17-0781

Details and patient eligibility

About

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 questionnaire will be used to document these symptoms.

Full 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 treatment using tacrolimus, with possible less Central Nervous Symptom (CNS) side effects. CNS side effects are one of the main reasons that patients complain about after having a kidney transplant while on tacrolimus (Prograf). The side effects can be debilitating and can affect the patient's overall well-being. In severe cases it may lead to non-compliance. The advantage of the study of using Envarsus is the ability to avoid these debilitating CNS side effects and afford better compliance with the patients taking the medicine.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.