Once Daily Immunosuppression Regimen

December 27, 2024 updated by: Washington University School of Medicine

Once a Day Immunosuppression Regimen: Outcomes and Compliance

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Once daily regimen
Once daily medication regimen (Envarsus and azathioprine)
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.
Active Comparator: Twice daily regimen
Twice daily medication regimen (Tacrolimus and mycophenolic acid)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months
Time Frame: 3 months and 12 months post transplant
BAASIS Survey
3 months and 12 months post transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Self-recorded Compliance and Tolerability of Medication Regimen at 3 and 12 Months
Time Frame: 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)
3 months and 12 months post transplant
Composite Endpoint Measurement
Time Frame: 12 months
Number of Participants with Biopsy proven Acute Rejection, graft loss, death, Lost to follow-up at 12 months.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Veloxis Pharmaceuticals

Investigators

  • Principal Investigator: Rowena Delos Santos, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2018

Primary Completion (Actual)

November 10, 2023

Study Completion (Actual)

November 10, 2023

Study Registration Dates

First Submitted

May 17, 2018

First Submitted That Met QC Criteria

May 31, 2018

First Posted (Actual)

June 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 27, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201803162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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