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| Name | Class |
|---|---|
| Veloxis Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Control | Active Comparator | Tacrolimus immediate release twice daily for 6 months |
|
| Arm 2: Intervention | Experimental | Envarsus daily for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Envarsus | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neurotoxicity Burden | Estimate the change from baseline to six months in neurotoxicity burden measured by a composite Patient Global Impression of Improvement score (PGI-I, with a range of 4-28) The PGI-I is a global index that may be used to rate the response of a condition to a therapy (transition scale). Scale min=4, scale max=28. The scale is made up of four questions, each question has a total of 7 responses, the total score is the sum of each questions choice (1-7). Higher values represent a worsening condition. A score of 16 would indicate no overall change. A score of 15 or lower indicates improvement in the condition and a score of 17 or higher indicates a worsening of the condition. A score of 28 would indicate "very much worse," while a score of 4 would indicate "very much better." A relative change of 2 points would be considered a significant change from baseline. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Derek Dubay, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41089174 | Derived | Coffman KS, Revuelta GJ, DeTurk N, Palmer C, Culpepper H, Overstreet M, Fleming J, Terry K, Patel N, McGillicuddy J, Nagaraju S, Rice TC, Taber DJ. Results of a Randomized Controlled Trial Evaluating the Impact of Conversion to LCP Tacrolimus on Neurologic Toxicities in Liver Transplant Recipients. Int J Hepatol. 2025 Oct 6;2025:4374144. doi: 10.1155/ijh/4374144. eCollection 2025. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Control | Tacrolimus immediate release twice daily for 6 months 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. |
| FG001 | Arm 2: Intervention | Envarsus daily for 6 months. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Control | Tacrolimus immediate release twice daily for 6 months 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. |
| BG001 | Arm 2: Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Neurotoxicity Burden | Estimate the change from baseline to six months in neurotoxicity burden measured by a composite Patient Global Impression of Improvement score (PGI-I, with a range of 4-28) The PGI-I is a global index that may be used to rate the response of a condition to a therapy (transition scale). Scale min=4, scale max=28. The scale is made up of four questions, each question has a total of 7 responses, the total score is the sum of each questions choice (1-7). Higher values represent a worsening condition. A score of 16 would indicate no overall change. A score of 15 or lower indicates improvement in the condition and a score of 17 or higher indicates a worsening of the condition. A score of 28 would indicate "very much worse," while a score of 4 would indicate "very much better." A relative change of 2 points would be considered a significant change from baseline. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
|
6 months post-transplant
SAE was defined as a hospitalization, prolonged hospitalization, graft loss or death.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Control | Tacrolimus immediate release twice daily for 6 months 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Rejection | Gastrointestinal disorders | SNOMED CT | Systematic Assessment | Liver rejection |
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Study conducted during COVID 19 pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor | Medical University of South Carolina | 8437922724 | taberd@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2020 | Apr 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Tacrolimus Immediate release | Drug | 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. |
|
Envarsus daily for 6 months. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Tacrolimus immediate release twice daily for 6 months
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.
| OG001 | Arm 2: Intervention | Envarsus daily for 6 months. 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. |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Arm 2: Intervention | Envarsus daily for 6 months. 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. | 0 | 15 | 1 | 15 | 0 | 15 |
|
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