Clinical trial NCT03555448: Once Daily Immunosuppression Regimen
Official title: Once a Day Immunosuppression Regimen: Outcomes and Compliance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Transplant; Complications
Keywords: Immunosuppression
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Veloxis Pharmaceuticals
First posted: 2018-06-13
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months
timeFrame: 3 months and 12 months post transplant
Secondary outcomes:
measure: Change in Self-recorded Compliance and Tolerability of Medication Regimen at 3 and 12 Months
timeFrame: 3 months and 12 months post transplant
measure: Composite Endpoint Measurement
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Rowena Delos Santos
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bunnapradist 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.
citation: Jamieson 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.
citation: Laliberte 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.
citation: Rostaing 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.
citation: Vrijens 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.