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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

Study Summary

This trial will compare the neurologic side effects of two immunosuppressant drugs used in liver transplant patients. One drug is given twice daily, and the other is given once daily. The trial hypothesis is that the once-daily drug will cause fewer neurologic side effects.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in neurotoxicity burden

Secondary outcome measures

Change in mean Fahn-Tolosa-Marin (FTM) score

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

Find a Location

Who is running the clinical trial?

Veloxis PharmaceuticalsIndustry Sponsor

41 Previous Clinical Trials

3,116 Total Patients Enrolled

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,585 Total Patients Enrolled

Derek Dubay, MDPrincipal InvestigatorMedical University of South Carolina

Media Library

Envarsus (Calcineurin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03823768 — Phase 4

Neurotoxicity Research Study Groups: Arm 2: Intervention, Arm 1: Control

Neurotoxicity Clinical Trial 2023: Envarsus Highlights & Side Effects. Trial Name: NCT03823768 — Phase 4

Envarsus (Calcineurin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03823768 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the estimated sample size for this clinical trial?

"This clinical trial has concluded its recruitment phase. It was initially posted on January 31st 2020 and last updated April 20th 2022. Fortunately, there are currently 45 liver transplant trials still admitting candidates, as well as 150 Envarsus studies searching for participants."

Answered by AI

Are there still opportunities for participants to join this clinical research?

"Based on the data available through clinicaltrials.gov, this trial is no longer recruiting patients as it was most recently updated in April of 2022. However, there are 195 other studies that have current openings for volunteers."

Answered by AI

Has Envarsus been certified by the FDA?

"Due to the progression of Envarsus through Phase 4 trials, Power rated this treatment as a 3 on its safety scale."

Answered by AI

What therapeutic purpose is Envarsus typically employed for?

"Envarsus is a common medication for the management of atopic dermatitis. Additionally, it can be employed to treat other ailments such as psoriasis, liver transplant rejection and kidney transplant rejection."

Answered by AI

Has Envarsus been utilized in previous research endeavors?

"At the present moment, there are 150 ongoing clinical trials assessing Envarsus. Of these investigations, 18 are in their final phase of research with 871 testing sites available. The majority of said locations can be found in Nashville, Tennessee."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Envarsus Neurotoxicity Burden in Liver Transplant Patients

David J. Taber 2020. "Envarsus Neurotoxicity Burden in Liver Transplant Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03823768.