NCT03555448

Once Daily Immunosuppression Regimen

Once a Day Immunosuppression Regimen: Outcomes and Compliance

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine whether an immunosuppressive maintenance regimen of Envarsus/azathioprine compared to a tacrolimus/ mycophenolic acid regimen is associated with better compliance, tolerability, and lower biopsy proven rejection.

Conditions

• Kidney Transplant; Complications

Interventions

Type	Name	Description
DRUG	Once daily immunosuppression regimen	Intervention focuses on the type of regimen, in this case the intervention arm will receive a once daily regimen for immunosuppression compared to the twice daily regimen.
DRUG	Twice daily immunosuppression regimen	This is the arm which we are designating the standard, which will be the comparison to the active drug arm.

Timeline

• Start date: 2018-06-04
• Primary completion: 2023-11-10
• Completion: 2023-11-10
• First posted: 2018-06-13
• Last updated: 2025-01-22
• Results posted: 2025-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study