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Once Daily Immunosuppression Regimen

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ClinicalTrials.gov Identifier: NCT03555448
Recruitment Status : Not yet recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Collaborator:
Veloxis Pharmaceuticals
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Kidney Transplant; Complications Drug: Once daily immunosuppression regimen Drug: Twice daily immunosuppression regimen Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

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.




Primary Outcome Measures :
  1. Change in Compliance and tolerability of medication regimen at 3 and 12 months [ Time Frame: 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 [ 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)

  2. Composite endpoint measurement [ Time Frame: 12 months ]
    Incidence of Biopsy proven Acute Rejection, graft loss, death, Lost to follow-up at 12 months.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555448


Contacts
Contact: Rowena Delos Santos, MD 314-362-8351 delossantos@wustl.edu
Contact: Tarek Alhamad, MD 314-362-8351 talhamad@wustl.edu

Sponsors and Collaborators
Washington University School of Medicine
Veloxis Pharmaceuticals
Investigators
Principal Investigator: Rowena Delos Santos Washington University School of Medicine

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03555448     History of Changes
Other Study ID Numbers: 201803162
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
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