Phase 2 Completed N=10 Randomized Treatment

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

Kidney Transplant Failure and Rejection

Source: ClinicalTrials.gov NCT03437577 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcomePrimary: Change in Controlled Oral Word Association Test (COWAT) — .44; -2.11; -0.88; -1.78 score on a scale

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 function in kidney transplant recipients

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Controlled Oral Word Association Test (COWAT)	.44; -2.11; -0.88; -1.78; 0.78; -0.44	—

Eligibility Criteria

Inclusion Criteria

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 Criteria

younger than 18 years of age;
older than 65 years of age;
Non-native level English speaker;
pregnant women
breastfeeding women

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03437577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.