Once Daily Immunosuppression Regimen

Phase 4

Recruiting

• Conditions: Kidney Transplant; Complications
• Interventions: Drug: Once daily immunosuppression regimen; Drug: Twice daily immunosuppression regimen

• Registration Number: NCT03555448
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-31
• Study Start: 2018-06-04
• Study First Posted: 2018-06-13
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-30
• Last Update Posted: 2023-01-04
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Once daily regimen	Once daily immunosuppression regimen	Once daily medication regimen (Envarsus and azathioprine)
Twice daily regimen	Twice daily immunosuppression regimen	Twice daily medication regimen (Tacrolimus and mycophenolic acid)

Primary Outcome Measures

Name	Time	Method
Change in Compliance and tolerability of medication regimen at 3 and 12 months	3 months and 12 months post transplant	BAASIS Survey

Secondary Outcome Measures

Name	Time	Method
Change in Self-recorded Compliance and tolerability of medication regimen at 3 and 12 months	3 months and 12 months post transplant	Pill Manager (personal medication record keeping for those who participants who choose to use this method of recording their self-administered medication)
Composite endpoint measurement	12 months	Incidence of Biopsy proven Acute Rejection, graft loss, death, Lost to follow-up at 12 months.

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States