Change from Prograf to Envarsus XR for Kidney Transplant

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Kidney TransplantChange from Prograf to Envarsus XR - Drug
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a different immunosuppressant drug may improve cognitive function in renal transplant patients.

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Similar Trials

1
Tacrolimus, Extended Release, (Envarsus Xr)
1
Envarsus XR
1
Envarsus XR

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Baseline to month 4

Baseline to Month 4
Change in quality of life
Baseline to month 4
Change in cognitive function on Trail making part A
Change in cognitive function on Trail making part B
Change in cognitive function-Global on Covid-19 telephone battery
Change in cognitive function-Global on RBANS
Change of quality of sleep
baseline to month 4
Impression of Improvement by CGI
Impression of Improvement by PGI

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Tacrolimus, Extended Release, (Envarsus Xr)
2
Envarsus XR
2
Envarsus XR

Trial Design

1 Treatment Group

Change from Prograf to Envarsus
1 of 1

Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Change from Prograf to Envarsus XR · No Placebo Group · Phase 4

Change from Prograf to Envarsus
Drug
Experimental Group · 1 Intervention: Change from Prograf to Envarsus XR · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to month 4

Who is running the clinical trial?

Veloxis PharmaceuticalsIndustry Sponsor
40 Previous Clinical Trials
3,051 Total Patients Enrolled
Vanderbilt University Medical CenterLead Sponsor
774 Previous Clinical Trials
601,057 Total Patients Enrolled
Anthonny Langone, MDPrincipal InvestigatorVUMC

Eligibility Criteria

Age 18 - 70 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing to commit to and comply with the schedule of study visits.
You are not taking any medications that could interfere with tacrolimus blood levels.
You are between 18 and 70 years of age.
References

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