Status:
COMPLETED
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
Lead Sponsor:
University of Minnesota
Conditions:
Kidney Transplant Failure and Rejection
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
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, partici...
Eligibility Criteria
Inclusion
- Male or female kidney transplant recipient;
- 18-65 years of age;
- receiving a kidney transplant from a living or deceased donor;
- if female, premenopausal and heterosexually active, must be using two forms of highly effective birth control (at least one of which must be a barrier method) which includes consistent and correct usage of established oral contraception, established intrauterine device or intrauterine system, or barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, starting at screening and throughout the study period and for 90 days after the final study drug administration;
- written informed consent to participate in the study
Exclusion
- younger than 18 years of age;
- older than 65 years of age;
- Non-native level English speaker;
- pregnant women
- breastfeeding women
Key Trial Info
Start Date :
May 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03437577
Start Date
May 8 2018
End Date
March 31 2020
Last Update
April 15 2021
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55414