What is the mechanism of action of this treatment?

The most common treatments for neurotoxicity, particularly in the context of immunosuppressants like Tacrolimus, work by inhibiting calcineurin, a protein phosphatase involved in activating T-cells of the immune system. This inhibition reduces the immune response, which is crucial in preventing organ rejection in transplant patients. Envarsus, a once-daily formulation of Tacrolimus, offers a more consistent drug release and potentially fewer neurotoxic side effects compared to immediate-release formulations. This matters for neurotoxicity patients as it can lead to improved adherence, better management of symptoms, and a reduction in the frequency and severity of neurotoxic events.

What side effects are associated with this type of intervention?

The most common side effects associated with immunosuppressants like Tacrolimus, including its once-daily formulation Envarsus, are neurologic in nature. These can include tremors, headaches, and peripheral neuropathy. Other potential side effects are nephrotoxicity, hypertension, and gastrointestinal disturbances. Envarsus is hypothesized to have a lower rate of neurologic side effects compared to immediate-release Tacrolimus, but both formulations share a similar side effect profile.

What prior FDA approvals exist?

The FDA has approved several immunosuppressant drugs for various conditions, including Tacrolimus, which is used to prevent organ rejection in transplant patients. Envarsus, a once-daily extended-release formulation of Tacrolimus, is being studied for its potential to reduce neurotoxic side effects compared to the immediate-release form. While specific FDA approvals for treating neurotoxicity with immunosuppressants are limited, the focus remains on optimizing formulations like Envarsus to minimize adverse neurological effects while maintaining immunosuppressive efficacy.

What other types of research exist?

Promising alternatives to Envarsus for neurotoxicity patients include Belatacept, which has shown a favorable safety profile and reduced neurotoxicity compared to calcineurin inhibitors, and Voclosporin, a novel calcineurin inhibitor with a potentially better safety profile. Both options should be discussed with a healthcare provider to determine suitability based on individual patient needs and conditions.

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Calcineurin Inhibitor

Tacrolimus vs Envarsus for Neurotoxicity in Liver Transplant Patients

Phase 4

Waitlist Available

Led By Derek Dubay, MD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is comparing two drugs used to prevent liver transplant rejection. It aims to see if a medication called Envarsus causes fewer nerve-related side effects than the standard Tacrolimus.

Who is the study for?

This trial is for adults over 18 who've had a liver or liver/kidney transplant in the last 6 months. They must understand and agree to the study's terms. It's not for pregnant or nursing individuals, HIV positive patients, those unable to take oral meds, recently used other investigational drugs, have certain rejection issues post-transplant, tremor-causing conditions, or are on tremor-inducing meds.

What is being tested?

The study compares two immunosuppressant medications: standard Tacrolimus (taken twice daily) versus Envarsus (once daily), focusing on their neurological side effects in liver transplant patients. The hypothesis suggests that Envarsus may lead to fewer neurologic side effects than Tacrolimus.

What are the potential side effects?

Possible side effects include neurotoxicity such as tremors and other neurological symptoms like headaches and sleep disturbances. Each medication has its own profile of potential side effects which will be closely monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Neurotoxicity Burden

Secondary study objectives

Change in Mean Fahn-Tolosa-Marin (FTM) Score

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2: InterventionExperimental Treatment1 Intervention

Envarsus daily for 6 months.

Group II: Arm 1: ControlActive Control1 Intervention

Tacrolimus immediate release twice daily for 6 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Envarsus

2020

Completed Phase 4

~130

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for neurotoxicity, particularly in the context of immunosuppressants like Tacrolimus, work by inhibiting calcineurin, a protein phosphatase involved in activating T-cells of the immune system. This inhibition reduces the immune response, which is crucial in preventing organ rejection in transplant patients. Envarsus, a once-daily formulation of Tacrolimus, offers a more consistent drug release and potentially fewer neurotoxic side effects compared to immediate-release formulations. This matters for neurotoxicity patients as it can lead to improved adherence, better management of symptoms, and a reduction in the frequency and severity of neurotoxic events.