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
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|ClinicalTrials.gov Identifier: NCT03437577|
Recruitment Status : Enrolling by invitation
First Posted : February 19, 2018
Last Update Posted : June 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplant Failure and Rejection||Drug: immediate-release tacrolimus Drug: extended release tacrolimus||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||May 8, 2018|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Active Comparator: immediate-release tacrolimus
This is standard of care
Drug: immediate-release tacrolimus
Standard of care for transplant patients
Other Name: Prograf
Experimental: extended release tacrolimus
replace standard of care
Drug: extended release tacrolimus
Other Name: Envarsus®XR.
- Controlled Oral Word Association [ Time Frame: change from baseline at 6,12, 24 weeks ]compare the effect of treatment with an immediate-release tacrolimus (i.e., Prograf®) to an extended-release tacrolimus (Envarsus® XR) immunosuppressive regiment on cognitive and motor function in kidney transplant recipients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437577
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55414|
|Principal Investigator:||Susan Marino, PhD||University of Minnesota - Clinical and Translational Science Institute|