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Envarsus Neurotoxicity Burden in Liver Transplant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03823768
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
Veloxis Pharmaceuticals
Information provided by (Responsible Party):
Medical University of South Carolina

Study Description
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Brief Summary:
This study will compare neurologic side effects associated with two immunosuppressant medications used in liver transplant patients. The standard therapy of twice daily immediate release Tacrolimus will be compared to Envarsus once daily. We hypothesize that Envarsus will show a lower rate of neurologic side effects than immediate release tacrolimus.

Condition or disease Intervention/treatment Phase
Neurotoxicity Liver Transplant; Complications Drug: Envarsus Drug: Tacrolimus Immediate release Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Conversion to Once-Daily Envarsus® on the Neurologic Toxicity Burden in Liver Transplant Recipients
Actual Study Start Date : January 31, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm 1: Control
Tacrolimus immediate release twice daily for 6 months
 Drug: Tacrolimus Immediate release
Subjects in this group will take Tacrolimus immediate release for 6 months of treatment (goal 12 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.
Experimental: Arm 2: Intervention
Envarsus daily for 6 months.
 Drug: Envarsus
Subjects in this group will take Envarsus daily for 6 months of treatment (goal 24 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.


Outcome Measures
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Primary Outcome Measures :
  1. Change in neurotoxicity burden [ Time Frame: 6 months ]
    Estimate the change from baseline to six months in neurotoxicity burden measured by a composite Patient Global Impression of Improvement score


Secondary Outcome Measures :
  1. Change in mean Fahn-Tolosa-Marin (FTM) score [ Time Frame: 6 months ]
    Estimate the change in the mean FTM score among patients with self-reported tremors from baseline to six months.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female adult (≥18 years old) with a history of liver or liver/kidney transplant within the first 6 months of transplant.
  2. Patients must be capable of understanding the purposes and risks of the study and have the ability to give written informed consent and be willing to participate and comply with the study.

Exclusion Criteria:

  1. Patients will be excluded if they are pregnant or nursing females or males with a pregnant female partner
  2. HIV positive (HIV ab +)
  3. Unable to tolerate oral medications
  4. Use of another investigational product within thirty days prior to receiving study medication
  5. Moderate acute cellular rejection (RAI ≥ 5) within the past month
  6. A condition that is known to cause tremor such as essential tremor, Parkinson disease, or enhanced physiologic tremor.
  7. Patients taking medications known to induce tremors or dopamine blocking agents
  8. A condition or disorder that, in the opinion of the investigator, may adversely affect the outcome of the study or the safety of the subject
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823768


Contacts
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Contact: David Taber, PharmD 843-792-2724 taberd@musc.edu
Contact: Caitlin Schaffner, MPH 843-792-7558 schaffne@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: David Taber, PharmD    843-792-2724      
Sponsors and Collaborators
Medical University of South Carolina
Veloxis Pharmaceuticals
Investigators
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Principal Investigator: Derek Dubay, MD Medical University of South Carolina
More Information
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03823768    
Other Study ID Numbers: 00083855
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020

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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.: Yes
Additional relevant MeSH terms:
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Neurotoxicity Syndromes
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Tacrolimus
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action