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The primary objective is to compare the effect of treatment with an immediate-release tacrolimus to an extended-release tacrolimus (i.e., Envarsus® XR) immunosuppressive regimen on cognitive and motor function in kidney transplant recipients
Between four (4) months and 14 months after receiving a kidney transplant and, per standard of care (SOC), having been placed on an immediate-release (IR) tacrolimus immunosuppressant regimen, participants in this study will undergo cognitive and motor function testing and have a blood sample collected (BASELINE). Half of the participants will then be randomly converted to extended-release (XR) tacrolimus (Envarsus® XR) while the other half will remain on IR tacrolimus for the duration of the study. Both the IR and XR groups will repeat the cognitive and motor function testing and have a blood sample collected at 6, 12, and 24 weeks Post-BASELINE. A practice version of the cognitive and motor function tests will be administered no more than 60 days prior to the baseline visit (Pre-BASELINE). Alternate versions of the cognitive and motor tests will be used at each Post-BASELINE testing session to control for possible practice effects.
The primary objective is to compare the effect of treatment with an immediate-release tacrolimus to an extended-release tacrolimus (i.e., Envarsus® XR) immunosuppressive regimen on cognitive and motor function in kidney transplant recipients.
The secondary objective is to determine the factors that explain inter-individual variability in cognitive response. Pharmacokinetic and demographic factors will be explored. Variability in cognitive response between individuals can be large. A population approach (nonlinear, mixed effects) will be used. Measurement of drug concentration will be the dependent variable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immediate-release tacrolimus | Active Comparator | This is standard of care |
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| extended release tacrolimus | Experimental | replace standard of care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immediate-release tacrolimus | Drug | Standard of care for transplant patients |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Controlled Oral Word Association Test (COWAT) | 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. | Change from baseline at 6,12, 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Marino, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate-Release Tacrolimus | This is standard of care immediate-release tacrolimus: Standard of care for transplant patients |
| FG001 | Extended-Release Tacrolimus | replace standard of care extended release tacrolimus: Experimental care |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pre-Randomization |
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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 6, 2019 |
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| extended release tacrolimus | Drug | Experimental care |
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| FG002 | Non-Randomized | Participants in this arm were not randomized to either arm. They ended study participation prior to randomization. |
| COMPLETED |
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| NOT COMPLETED |
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| Post-Randomization |
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All participants are included at baseline, including those who withdrew participant prior to randomization
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate-Release Tacrolimus | This is standard of care immediate-release tacrolimus: Standard of care for transplant patients |
| BG001 | Extended-Release Tacrolimus | replace standard of care extended release tacrolimus: Experimental care |
| BG002 | Non-Randomized | Participants in this arm were not randomized to either arm. They ended study participation prior to randomization. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 Controlled Oral Word Association Test (COWAT) | 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. | All participants who were randomized and participated in outcome measure data collection are included. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline at 6,12, 24 weeks |
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24 weeks
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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 | Immediate-Release Tacrolimus | This is standard of care immediate-release tacrolimus: Standard of care for transplant patients | 0 | 3 | 0 | 3 | 0 | 3 |
| EG001 | Extended-Release Tacrolimus | replace standard of care extended release tacrolimus: Experimental care | 0 | 5 | 0 | 5 | 0 | 5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Marino | University of Minnesota | 612-624-2964 | marin007@umn.edu |
| Feb 25, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 26, 2018 | Feb 25, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Basline to 24 weeks |
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