Once Daily Immunosuppression Regimen

Kidney Transplant; Complications Clinical Trial

Official title:

Once a Day Immunosuppression Regimen: Outcomes and Compliance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03555448
• Other study ID #: 201803162
• Status: Recruiting
• Phase: Phase 4
• Start date: June 4, 2018
• Est. completion date: December 2025

Study information

• Verified date: December 2022
• Source: Washington University School of Medicine
• Contact: Rowena Delos Santos, MD
• Phone: 314-362-8351
• Email: delossantos[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant; Complications

Intervention

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.
• Twice daily immunosuppression regimen
This is the arm which we are designating the standard, which will be the comparison to the active drug arm.

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Veloxis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Compliance and tolerability of medication regimen at 3 and 12 months	BAASIS Survey	3 months and 12 months post transplant
Secondary	Change in Self-recorded Compliance and tolerability of medication regimen at 3 and 12 months	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
Secondary	Composite endpoint measurement	Incidence of Biopsy proven Acute Rejection, graft loss, death, Lost to follow-up at 12 months.	12 months