CNS Study of Patients Switching From Tacrolimus to Envarsus

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Transplant Patients
• Intervention / Treatment: Drug: Envarsus XR

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 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
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Lisa Kornfeld

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Laurence Chan, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): May 2, 2020
• Study Completion (Actual): June 2, 2020

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: 17-0781

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No