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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

Tracking Information
First Submitted Date  ICMJE January 29, 2019
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date February 24, 2020
Actual Study Start Date  ICMJE January 31, 2020
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
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 Improvmenet score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Envarsus Neurotoxicity Burden in Liver Transplant Patients
Official Title  ICMJE The Effect of Conversion to Once-Daily Envarsus® on the Neurologic Toxicity Burden in Liver Transplant Recipients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neurotoxicity
  • Liver Transplant; Complications
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Arm 1: Control
    Tacrolimus immediate release twice daily for 6 months
    Intervention: Drug: Tacrolimus Immediate release
  • Experimental: Arm 2: Intervention
    Envarsus daily for 6 months.
    Intervention: Drug: Envarsus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Taber, PharmD 843-792-2724 taberd@musc.edu
Contact: Caitlin Schaffner, MPH 843-792-7558 schaffne@musc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03823768
Other Study ID Numbers  ICMJE 00083855
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Veloxis Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Derek Dubay, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP