Once Daily Immunosuppression Regimen

The Washington University

Status and phase: Terminated; Phase 4

Conditions: Kidney Transplant; Complications

Treatments: Drug: Twice daily immunosuppression regimen; Drug: Once daily immunosuppression regimen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03555448

201803162

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >/= 18 years old
• Kidney transplant recipient
• Thymoglobulin induction

Exclusion criteria

• Non-renal organ transplant
• Combined organ transplant
• Inability to receive Envarsus after transplant
• Discharged to acute care facility after transplant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

51 participants in 2 patient groups

Once daily regimen

Active Comparator group

Description:

Once daily medication regimen (Envarsus and azathioprine)

Treatment:

Drug: Once daily immunosuppression regimen

Twice daily regimen

Active Comparator group

Description:

Twice daily medication regimen (Tacrolimus and mycophenolic acid)

Treatment:

Drug: Twice daily immunosuppression regimen