Study Stopped
poor recruitment during pandemic and after
Once Daily Immunosuppression Regimen
Once a Day Immunosuppression Regimen: Outcomes and Compliance
1 other identifier
interventional
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2018
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2018
CompletedStudy Start
First participant enrolled
June 4, 2018
CompletedFirst Posted
Study publicly available on registry
June 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2023
CompletedResults Posted
Study results publicly available
January 22, 2025
CompletedJanuary 22, 2025
December 1, 2024
5.4 years
May 17, 2018
December 6, 2024
December 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months
BAASIS Survey
3 months and 12 months post transplant
Secondary Outcomes (2)
Change in Self-recorded Compliance and Tolerability of Medication Regimen at 3 and 12 Months
3 months and 12 months post transplant
Composite Endpoint Measurement
12 months
Study Arms (2)
Once daily regimen
ACTIVE COMPARATOROnce daily medication regimen (Envarsus and azathioprine)
Twice daily regimen
ACTIVE COMPARATORTwice daily medication regimen (Tacrolimus and mycophenolic acid)
Interventions
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.
This is the arm which we are designating the standard, which will be the comparison to the active drug arm.
Eligibility Criteria
You may qualify if:
- Age \>/= 18 years old
- Kidney transplant recipient
- Thymoglobulin induction
You may not qualify if:
- Non-renal organ transplant
- Combined organ transplant
- Inability to receive Envarsus after transplant
- Discharged to acute care facility after transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- Veloxis Pharmaceuticalscollaborator
Study Sites (1)
Washington University
St Louis, Missouri, 63110, United States
Related Publications (6)
Budde K, Bunnapradist S, Grinyo JM, Ciechanowski K, Denny JE, Silva HT, Rostaing L; Envarsus study group. Novel once-daily extended-release tacrolimus (LCPT) versus twice-daily tacrolimus in de novo kidney transplants: one-year results of Phase III, double-blind, randomized trial. Am J Transplant. 2014 Dec;14(12):2796-806. doi: 10.1111/ajt.12955. Epub 2014 Oct 2.
PMID: 25278376BACKGROUNDBunnapradist S, Ciechanowski K, West-Thielke P, Mulgaonkar S, Rostaing L, Vasudev B, Budde K; MELT investigators. Conversion from twice-daily tacrolimus to once-daily extended release tacrolimus (LCPT): the phase III randomized MELT trial. Am J Transplant. 2013 Mar;13(3):760-9. doi: 10.1111/ajt.12035. Epub 2012 Dec 21.
PMID: 23279614BACKGROUNDJamieson NJ, Hanson CS, Josephson MA, Gordon EJ, Craig JC, Halleck F, Budde K, Tong A. Motivations, Challenges, and Attitudes to Self-management in Kidney Transplant Recipients: A Systematic Review of Qualitative Studies. Am J Kidney Dis. 2016 Mar;67(3):461-78. doi: 10.1053/j.ajkd.2015.07.030. Epub 2015 Sep 11.
PMID: 26372087BACKGROUNDLaliberte F, Nelson WW, Lefebvre P, Schein JR, Rondeau-Leclaire J, Duh MS. Impact of daily dosing frequency on adherence to chronic medications among nonvalvular atrial fibrillation patients. Adv Ther. 2012 Aug;29(8):675-90. doi: 10.1007/s12325-012-0040-x. Epub 2012 Aug 15.
PMID: 22898791BACKGROUNDRostaing L, Bunnapradist S, Grinyo JM, Ciechanowski K, Denny JE, Silva HT Jr, Budde K; Envarsus Study Group. Novel Once-Daily Extended-Release Tacrolimus Versus Twice-Daily Tacrolimus in De Novo Kidney Transplant Recipients: Two-Year Results of Phase 3, Double-Blind, Randomized Trial. Am J Kidney Dis. 2016 Apr;67(4):648-59. doi: 10.1053/j.ajkd.2015.10.024. Epub 2015 Dec 22.
PMID: 26717860BACKGROUNDVrijens B, Heidbuchel H. Non-vitamin K antagonist oral anticoagulants: considerations on once- vs. twice-daily regimens and their potential impact on medication adherence. Europace. 2015 Apr;17(4):514-23. doi: 10.1093/europace/euu311. Epub 2015 Feb 17.
PMID: 25694538BACKGROUND
Results Point of Contact
- Title
- R. Delos Santos
- Organization
- Washington University
Study Officials
- PRINCIPAL INVESTIGATOR
Rowena Delos Santos
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2018
First Posted
June 13, 2018
Study Start
June 4, 2018
Primary Completion
November 10, 2023
Study Completion
November 10, 2023
Last Updated
January 22, 2025
Results First Posted
January 22, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share