CNS Study of Patients Switching From Tacrolimus to Envarsus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study of Stable Kidney Transplant Recipients Taking Tacrolimus With CNS Symptoms Switched to Envarsus

Conditions
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Renal Transplant Patients

Intervention / Treatment
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* Drug: Envarsus XR


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Envarsus XR<br>A form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant. | Drug: Envarsus XR<br>* 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.<br>* Other names: Tacrolimus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 1 Month, 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic Tacrolimus Drug Levels | The Investigators will evaluate Tacrolimus drug levels and will document any adverse events associated with this measure. | 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. | Baseline, 1 Month, 6 Months |