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Once Daily Immunosuppression Regimen

NCT03555448 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-01-22

Study results available
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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

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.

Sponsors & Collaborators

  • Veloxis Pharmaceuticals

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Rowena Delos Santos · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-04
Primary Completion
2023-11-10
Completion
2023-11-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03555448 on ClinicalTrials.gov