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Trial Outcomes & Findings for Envarsus Neurotoxicity Burden in Liver Transplant Patients (NCT NCT03823768)

NCT ID: NCT03823768

Last Updated: 2025-03-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

6 months

Results posted on

2025-03-30

Participant Flow

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
15
15
Overall Study
COMPLETED
15
15
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Envarsus Neurotoxicity Burden in Liver Transplant Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm 1: Control
n=15 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.
Arm 2: Intervention
n=15 Participants
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.
Total
n=30 Participants
Total of all reporting groups
Age, Categorical
>=65 years
1 Participants
n=93 Participants
1 Participants
n=4 Participants
2 Participants
n=27 Participants
Age, Continuous
51 years
STANDARD_DEVIATION 13 • n=93 Participants
52 years
STANDARD_DEVIATION 9 • n=4 Participants
52 years
STANDARD_DEVIATION 11 • n=27 Participants
Sex: Female, Male
Female
9 Participants
n=93 Participants
13 Participants
n=4 Participants
22 Participants
n=27 Participants
Sex: Female, Male
Male
6 Participants
n=93 Participants
2 Participants
n=4 Participants
8 Participants
n=27 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
n=93 Participants
14 Participants
n=4 Participants
28 Participants
n=27 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=93 Participants
2 Participants
n=4 Participants
3 Participants
n=27 Participants
Race (NIH/OMB)
White
14 Participants
n=93 Participants
13 Participants
n=4 Participants
27 Participants
n=27 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Region of Enrollment
United States
15 participants
n=93 Participants
15 participants
n=4 Participants
30 participants
n=27 Participants

PRIMARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure
Arm 1: Control
n=15 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.
Arm 2: Intervention
n=15 Participants
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.
Change in Neurotoxicity Burden
-5 score on a scale
Interval -13.5 to -0.25
-4 score on a scale
Interval -9.5 to -0.5

Adverse Events

Arm 1: Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Arm 2: Intervention

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Arm 1: Control
n=15 participants at risk
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.
Arm 2: Intervention
n=15 participants at risk
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.
Gastrointestinal disorders
Acute Rejection
0.00%
0/15 • 6 months post-transplant
SAE was defined as a hospitalization, prolonged hospitalization, graft loss or death.
6.7%
1/15 • Number of events 1 • 6 months post-transplant
SAE was defined as a hospitalization, prolonged hospitalization, graft loss or death.

Other adverse events

Adverse event data not reported

Additional Information

Professor

Medical University of South Carolina

Phone: 8437922724

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place