CNS Study of Patients Switching From Tacrolimus to Envarsus

University of Colorado, Denver20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Transplant Patients

Interventions

Envarsus XRDRUG

Pilot study documenting the neurotoxic side effects including tremors in patients with stable graft who are receiving Tacrolimus (Envarsus XR) following kidney transplantation. Standardized questionnaire will be used to document these symptoms.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Lisa Kornfeld

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Change in Quality of Life

The Investigators will evaluate the quality of life between baseline and 6 months related to sleep disturbance and upper extremity fine motor skills/ADL (activities of daily living), with the goal to be an improvement in their quality of life. This was assessed via a study-specific clinical assessment that evaluated patient reports of hand tremor and related complaints, and scored in a range of 0 to 3, with higher scores indicating worse symptoms of hand tremor, and a lower QOL.

Time frame: Baseline, 1 Month, 6 Months

Secondary Outcomes

Therapeutic Tacrolimus Drug Levels

The Investigators will evaluate Tacrolimus drug levels and will document any adverse events associated with this measure.

Time frame: Baseline, 1 Month, 6 Months

Kidney Function: Serum Creatinine Levels

The Investigators will evaluate serum creatinine levels and will document any adverse events associated with this measure.

Time frame: Baseline, 1 Month, 6 Months

Data from ClinicalTrials.gov

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