NCT02954198

Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

With the availability of well-studied once-daily formulations of tacrolimus, the ability to achieve a true once-daily immunosuppressant regimen along with everolimus and steroids may finally be achievable and have the potential to optimize immunosuppression safety and efficacy in kidney transplantation.

Detailed description

A once-daily immunosuppressant regimen comprising of Envarsus-everolimus-prednisone will have 6-month treatment failure rates that are non-inferior to the twice-daily regimen of Envarsus-mycophenolate mofetil-prednisone and will have improved patient-reported adherence.

Conditions

• Immunosuppression

Interventions

Type	Name	Description
DRUG	Tacrolimus	goal trough level 5-12ng/mL
DRUG	Prednisone	goal dose 5mg QD
DRUG	Mycophenolate mofetil	goal dose 1g BID
DRUG	Everolimus	goal trough level 3-8ng/mL

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-12-27
• Completion: 2018-12-27
• First posted: 2016-11-03
• Last updated: 2019-12-24
• Results posted: 2019-12-24

Locations

1 site across 1 country: United States