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Once Daily Immunosuppression Regimen

Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT03555448
Collaborator
Veloxis Pharmaceuticals (Industry)
100
Enrollment
1
Location
2
Arms
65.9
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Once daily immunosuppression regimen
  • Drug: Twice daily immunosuppression regimen
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Once a Day Immunosuppression Regimen: Outcomes and Compliance
Actual Study Start Date :
Jun 4, 2018
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. Composite endpoint measurement [12 months]

    Incidence of Biopsy proven Acute Rejection, graft loss, death, Lost to follow-up at 12 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine
  • Veloxis Pharmaceuticals

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03555448
Other Study ID Numbers:
  • 201803162
First Posted:
Jun 13, 2018
Last Update Posted:
Nov 15, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Washington University School of Medicine
Immunosuppression

Study Results

No Results Posted as of Nov 15, 2021