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
Completed · Phase 1/Phase 2
Conditions studied: Kidney Transplant Failure and Rejection
In brief
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
Key facts
- Study ID
- NCT03437577
- Run by
- University of Minnesota
- People needed
- 18
- Starts
- 2018-05-08
- Expected to finish
- 2020-03-31
- Last updated by the study team
- 2021-04-15
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- younger than 18 years of age;
- older than 65 years of age;
- Non-native level English speaker;
- pregnant women
- breastfeeding women
Where it is running
- University of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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