Trial Outcomes & Findings for Cognitive Outcomes in Stable Renal Transplant Patients Switched fromTacrolimus to Envarsus XR™ (NCT NCT04838288)
NCT ID: NCT04838288
Last Updated: 2026-04-29
Results Overview
Due to safety precautions for COVID-19 precluding us from seeing patients in person, neurocognitive function was assessed via a phone battery derived from standard cognitive tests and proven feasible and valid to assess memory, attention, reasoning, and executive function, including TICS (Telephone interview for Cognitive Testing: Scale of 0-41, \<26= mild cognitive impairment), WAIS-IV (Digit Span and Similarities: Scale of 1-19, \<=6 impairment), WMS-IV (Logical Memory Subsets I \& II: Scale of 1-19, \<=6 impairment), Controlled Oral Word Association (COWA: Scale of 0-53, \<=35 impairment), and Hayling Sentence Completion (Scale of 1-10, \<= 3.7 impairment).
COMPLETED
PHASE4
56 participants
Baseline to month 4
2026-04-29
Participant Flow
Single center - Vanderbilt University Medical Center Recruitment proceeded from May 2020 until April 2024.
Participant milestones
| Measure |
Once-daily Tacrolimus
Participants agree to switch from twice-daily version tacrolimus to once-daily version tacrolimus
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Outcomes in Stable Renal Transplant Patients Switched fromTacrolimus to Envarsus XR™
Baseline characteristics by cohort
| Measure |
Once-daily Tacrolimus
n=56 Participants
Participants agree to switch from twice-daily version tacrolimus to once-daily version tacrolimus
|
|---|---|
|
Age, Continuous
|
54 Years
n=9 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
White Race
|
43 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
13 Participants
n=9 Participants
|
|
Years of Education
|
14 Years
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline to month 4Due to safety precautions for COVID-19 precluding us from seeing patients in person, neurocognitive function was assessed via a phone battery derived from standard cognitive tests and proven feasible and valid to assess memory, attention, reasoning, and executive function, including TICS (Telephone interview for Cognitive Testing: Scale of 0-41, \<26= mild cognitive impairment), WAIS-IV (Digit Span and Similarities: Scale of 1-19, \<=6 impairment), WMS-IV (Logical Memory Subsets I \& II: Scale of 1-19, \<=6 impairment), Controlled Oral Word Association (COWA: Scale of 0-53, \<=35 impairment), and Hayling Sentence Completion (Scale of 1-10, \<= 3.7 impairment).
Outcome measures
| Measure |
Once-daily Tacrolimus
n=56 Participants
Participants agree to switch from twice-daily version tacrolimus to once-daily version tacrolimus
|
|---|---|
|
Change in Cognitive Function-Global on Covid-19 Telephone Battery
TICS (Telephone interview for Cognitive Testing)
|
34 Units on a scale
Interval 32.75 to 36.0
|
|
Change in Cognitive Function-Global on Covid-19 Telephone Battery
WMS-IV (Logical Memory I)
|
9 Units on a scale
Interval 8.0 to 11.0
|
|
Change in Cognitive Function-Global on Covid-19 Telephone Battery
WAIS-4: Digit Span
|
10 Units on a scale
Interval 8.0 to 12.0
|
|
Change in Cognitive Function-Global on Covid-19 Telephone Battery
WAIS-4: Similarities
|
10 Units on a scale
Interval 8.0 to 12.0
|
|
Change in Cognitive Function-Global on Covid-19 Telephone Battery
Controlled Oral Word Association (COWA)
|
44 Units on a scale
Interval 38.0 to 50.25
|
|
Change in Cognitive Function-Global on Covid-19 Telephone Battery
Hayling Sentence Completion
|
6 Units on a scale
Interval 4.0 to 6.0
|
|
Change in Cognitive Function-Global on Covid-19 Telephone Battery
WMS-IV (Logical Memory II)
|
10 Units on a scale
Interval 7.0 to 11.0
|
PRIMARY outcome
Timeframe: Baseline to month 4Population: The Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS) was to be administered as an in person setting. COVID pandemic prevented in person interactions. No data was collected. The IRB did not require an updated protocol to reflect the inability to collect data using the RBANS survey, and study has been closed by the IRB.
Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS). The total score represents the simple sum of the five cognitive domain index scores (Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory). Scores range from 40-160, with 160 referring to higher cognitive functioning.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to month 4Population: Trail Making Part A assessment was to be administered as an in person setting. COVID pandemic prevented in person interactions. No data was collected. The IRB did not require an updated protocol to reflect the inability to collect data using the Trailmaking survey, and study has been closed by the IRB.
Measured by Trail Making Part A. Maximum time given for TMT A is 150 seconds. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to month 4Population: Trail Making Part B assessment was to be administered as an in person setting. COVID pandemic prevented in person interactions. No data was collected. The IRB did not require an updated protocol to reflect the inability to collect data using the Trailmaking survey, and study has been closed by the IRB.
Measured by Trail Making Part B. Maximum time given for TMT B is 300 seconds. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Month 4Change in quality of life measured by WHODAS. The total score of WHODAS is the sum of all the 12 sub-scores and ranges from 0 to 48, with lower scores indicating better functioning. Total scores of 1-4 belong to mild disability, 5-9 to moderate disability, and 10-48 to severe disability
Outcome measures
| Measure |
Once-daily Tacrolimus
n=56 Participants
Participants agree to switch from twice-daily version tacrolimus to once-daily version tacrolimus
|
|---|---|
|
Change in Quality of Life
|
4 Units on a scale
Interval 1.0 to 8.0
|
SECONDARY outcome
Timeframe: baseline to month 4Population: Percentage of participants who reported much better in their score.
measured by PGI-I (Patient's Global Impression of Improvement). The PGI-I measures change since initiating a medication and is assessed on a 7-point Likert-type scale ranging from very much better (1) to very much worse (7)
Outcome measures
| Measure |
Once-daily Tacrolimus
n=56 Participants
Participants agree to switch from twice-daily version tacrolimus to once-daily version tacrolimus
|
|---|---|
|
Impression of Improvement by PGI
|
44 Participants
|
SECONDARY outcome
Timeframe: baseline to month 4Population: Participants who rated improvement as much better.
measured by CGI-I (Clinical Global Impression of Improvement). The CGI-I measures change since initiating a medication and is assessed on a 7-point Likert-type scale ranging from very much improved (1) to very much worse (7).
Outcome measures
| Measure |
Once-daily Tacrolimus
n=56 Participants
Participants agree to switch from twice-daily version tacrolimus to once-daily version tacrolimus
|
|---|---|
|
Impression of Improvement by CGI
|
32 Participants
|
SECONDARY outcome
Timeframe: Baseline to month 4measured by PIRS-20 (Pittsburgh Insomnia Rating Scale). The PIRS-20 total score is the sum of all items and ranges from 0 (good sleep) to 60 (bad sleep).3
Outcome measures
| Measure |
Once-daily Tacrolimus
n=56 Participants
Participants agree to switch from twice-daily version tacrolimus to once-daily version tacrolimus
|
|---|---|
|
Change of Quality of Sleep
|
10 Units on a scale
Interval 3.75 to 16.25
|
Adverse Events
Once-daily Tacrolimus
Serious adverse events
| Measure |
Once-daily Tacrolimus
n=56 participants at risk
Participants agree to switch from twice-daily version tacrolimus to once-daily version tacrolimus
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
1.8%
1/56 • Number of events 2 • From enrollment until end of follow-up, approximately 8-months
|
Other adverse events
| Measure |
Once-daily Tacrolimus
n=56 participants at risk
Participants agree to switch from twice-daily version tacrolimus to once-daily version tacrolimus
|
|---|---|
|
Infections and infestations
COVID
|
10.7%
6/56 • Number of events 6 • From enrollment until end of follow-up, approximately 8-months
|
Additional Information
Anthony Langone, MD
Vanderbilt University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place