Once Daily Immunosuppression Regimen

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-04

Study Completion Date

2023-11-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Transplant; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Once daily regimen

Once daily medication regimen (Envarsus and azathioprine)

Group Type ACTIVE_COMPARATOR

Once daily immunosuppression regimen

Intervention Type DRUG

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.

Twice daily regimen

Twice daily medication regimen (Tacrolimus and mycophenolic acid)

Group Type ACTIVE_COMPARATOR

Twice daily immunosuppression regimen

Intervention Type DRUG

This is the arm which we are designating the standard, which will be the comparison to the active drug arm.

Interventions

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