Trial Outcomes & Findings for Comparison of the Cognitive and Motor Effects of Treatment Between an Immediate- and Extended-release Tacrolimus (Envarsus® XR) Based Immunosuppression Regimen in Kidney Transplant Recipients (NCT NCT03437577)

Last Updated: 2021-04-15

Results Overview

During The Controlled Oral Word Association Test (COWAT), participants are asked to make verbal associations to different letters of the alphabet by saying all the words which they can think of beginning with a given letter. Three letters of progressively increasing associative difficulty are presented with 60 seconds allotted per letter for word retrieval. Scores are calculated as a sum of the total words produced across the 3 letter trials. The lowest possible score is zero, meaning no words could be produced. There is no limit to the higher end of the scale given that participants can produce as many words as possible for each of the three letters. Higher scores indicate greater word retrieval and better cognitive function. Outcome is reported as the change in COWAT between baseline and 6 weeks, baseline and 12 weeks, and baseline and 24 weeks.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Change from baseline at 6,12, 24 weeks

Results posted on

2021-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	Immediate-Release Tacrolimus This is standard of care immediate-release tacrolimus: Standard of care for transplant patients	Extended-Release Tacrolimus replace standard of care extended release tacrolimus: Experimental care	Non-Randomized Participants in this arm were not randomized to either arm. They ended study participation prior to randomization.
Pre-Randomization STARTED	0	0	10
Pre-Randomization COMPLETED	0	0	0
Pre-Randomization NOT COMPLETED	0	0	10
Post-Randomization STARTED	3	5	0
Post-Randomization COMPLETED	3	3	0
Post-Randomization NOT COMPLETED	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Immediate-Release Tacrolimus This is standard of care immediate-release tacrolimus: Standard of care for transplant patients	Extended-Release Tacrolimus replace standard of care extended release tacrolimus: Experimental care	Non-Randomized Participants in this arm were not randomized to either arm. They ended study participation prior to randomization.
Pre-Randomization Withdrawal by Subject	0	0	10
Post-Randomization Physician Decision	0	2	0

Baseline Characteristics

Comparison of the Cognitive and Motor Effects of Treatment Between an Immediate- and Extended-release Tacrolimus (Envarsus® XR) Based Immunosuppression Regimen in Kidney Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate-Release Tacrolimus n=3 Participants This is standard of care immediate-release tacrolimus: Standard of care for transplant patients	Extended-Release Tacrolimus n=5 Participants replace standard of care extended release tacrolimus: Experimental care	Non-Randomized n=10 Participants Participants in this arm were not randomized to either arm. They ended study participation prior to randomization.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants	18 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	52.3 years STANDARD_DEVIATION 9.5 • n=5 Participants	60.4 years STANDARD_DEVIATION 1.9 • n=7 Participants	49.2 years STANDARD_DEVIATION 10 • n=5 Participants	52.8 years STANDARD_DEVIATION 9.7 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants	18 participants n=4 Participants

PRIMARY outcome

Timeframe: Change from baseline at 6,12, 24 weeks

Population: All participants who were randomized and participated in outcome measure data collection are included.

Outcome measures

Outcome measures
Measure	Immediate-Release Tacrolimus n=3 Participants This is standard of care immediate-release tacrolimus: Standard of care for transplant patients	Extended-Release Tacrolimus n=5 Participants replace standard of care extended release tacrolimus: Experimental care
Change in Controlled Oral Word Association Test (COWAT) Baseline to 6 weeks	.44 score on a scale Standard Deviation .51	-2.11 score on a scale Standard Deviation 2.83
Change in Controlled Oral Word Association Test (COWAT) Baseline to 12 weeks	-0.88 score on a scale Standard Deviation 1.89	-1.78 score on a scale Standard Deviation 2.01
Change in Controlled Oral Word Association Test (COWAT) Basline to 24 weeks	0.78 score on a scale Standard Deviation .84	-0.44 score on a scale Standard Deviation 2.04

Adverse Events

Immediate-Release Tacrolimus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Extended-Release Tacrolimus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Susan Marino

University of Minnesota

Phone: 612-624-2964

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place