Phase 4
N=233
Envarsus XR Compared to Immediate Release Tacrolimus
Kidney Transplant Recipients
Bottom Line
View on ClinicalTrials.gov: NCT03979365 ↗Enrolled (actual)
233
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Mean Change in Calcineurin Inhibitor-related Symptoms Severity Score — -2.977; -3.139 score on a scale — p=0.944
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Envarsus XR (Drug); Tacrolimus twice daily (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Calcineurin Inhibitor-related Symptoms Severity Score |
-2.977; -3.139 | 0.944 |
| SECONDARY Change in the Severity Score in Each of the Five Individual CIRS Items |
0; 0; 0; 0; 0; 0 | 0.345 |
| SECONDARY Number of Subjects With a Moderately Severe, Severe or Very Severe Score on Any CIRS Item |
18; 28 | 0.010 sig |
| SECONDARY Change in the Number of Subjects Who Had a Reduction in Severity of Calcineurin Inhibitor-related Symptoms |
8; 8 | — |
| SECONDARY Change in the Number of Subjects Who Had at Least One Calcineurin Inhibitor-related Symptom Reduced by 1 Point or Greater |
43; 30 | — |
| SECONDARY Transplant-related Symptoms as Measured by the Difference in Mean Transplant-related Symptoms (TRS) Score. |
-1.375; -1.069 | 0.836 |
| SECONDARY Change in Health-related Quality of Life (HRQoL), as Measured by the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Health Profile. |
-10; -20 | 0.008 sig |
| SECONDARY Change in Transplant-related Symptoms as Measured by the Difference in Transplant-related Symptoms (TRS) Score in for Each Individual Symptom |
0; 0; 0; 0; 0; 0 | 0.314 |
| SECONDARY Change in Overall Tolerability or Patient Bother Due to Side Effects |
0; 0 | 0.754 |
| SECONDARY Change in Medication Adherence |
— | — |
| SECONDARY Change in Patient Medication Satisfaction as Assessed by Question 14 of the Treatment Satisfaction Questionnaire for Medication. |
0; 1 | 0.371 |
| SECONDARY Correlation Between de Novo DSA and Degree of Taking and Timing Adherence |
— | — |
| SECONDARY Adverse Events |
0; 0 | — |
Summary
The purpose of this study is to compare once-daily tacrolimus extended-release (Envarsus XR®) to twice-daily immediate release tacrolimus to find out if people taking tacrolimus extended release (Envarsus XR®) report fewer side effects, increased medication compliance and higher scores on quality of life assessments compared to people taking twice daily tacrolimus immediate release.
Eligibility Criteria
Inclusion Criteria
- Patient is an adult (18 years of age or older).
- Treatment with Envarsus XR® or immediate-release, twice-daily tacrolimus has been indicated by patient's transplant care team.
- Patient is a recipient of a deceased or living donor kidney transplant.
- Patient is able to comply with study procedures for the entire length of the study.
- Patient has been informed about the study survey and has signed an informed consent form.
Exclusion Criteria
- Patient is unable or unwilling to complete study patient reported outcome questionnaires.
- Patient is currently receiving azathioprine
- Patient is currently receiving an mTOR inhibitor (sirolimus, everolimus)
- Patient is currently receiving an belatacept
- Patient has received investigational immunosuppression 1 month prior to transplant or post-transplant
- Patient is in a setting where a professional care taker is responsible for dispensing subject's medication.
Data sourced from ClinicalTrials.gov (NCT03979365). 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.