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poor recruitment during pandemic and after
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| Name | Class |
|---|---|
| Veloxis Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Once daily regimen | Active Comparator | Once daily medication regimen (Envarsus and azathioprine) |
|
| Twice daily regimen | Active Comparator | Twice daily medication regimen (Tacrolimus and mycophenolic acid) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Once daily immunosuppression regimen | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | BAASIS Survey | 3 months and 12 months post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Composite Endpoint Measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rowena Delos Santos | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25278376 | Background | 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. | |
| 23279614 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Once Daily Regimen | Once daily medication regimen (Envarsus and azathioprine) 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. |
| FG001 | Twice Daily Regimen | Twice daily medication regimen (Tacrolimus and mycophenolic acid) Twice daily immunosuppression regimen: This is the arm which we are designating the standard, which will be the comparison to the active drug arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Once Daily Regimen | Once daily medication regimen (Envarsus and azathioprine) 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months | BAASIS Survey | Posted | Number | participants | 3 months and 12 months post transplant |
|
1 year from time of transplant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Once Daily Regimen | Once daily medication regimen (Envarsus and azathioprine) 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AKI | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dialysis access issue (clotting/bleeding) | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| R. Delos Santos | Washington University | 3143628351 | delossantos@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2019 | Dec 6, 2024 | Prot_SAP_000.pdf |
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| Twice daily immunosuppression regimen | Drug | This is the arm which we are designating the standard, which will be the comparison to the active drug arm. |
|
Number of Participants with Biopsy proven Acute Rejection, graft loss, death, Lost to follow-up at 12 months. |
| 12 months |
| 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. |
| 26372087 | Background | 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. |
| 22898791 | Background | 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. |
| 26717860 | Background | 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. |
| 25694538 | Background | 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. |
| Twice Daily Regimen |
Twice daily medication regimen (Tacrolimus and mycophenolic acid) Twice daily immunosuppression regimen: This is the arm which we are designating the standard, which will be the comparison to the active drug arm. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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) | There are Zero "0" patients in study who used the pill manager during the study. No data were collected | Posted | 3 months and 12 months post transplant |
|
|
| Secondary | Composite Endpoint Measurement | Number of Participants with Biopsy proven Acute Rejection, graft loss, death, Lost to follow-up at 12 months. | Posted | Number | participants | 12 months |
|
|
|
| 1 |
| 23 |
| 9 |
| 23 |
| 1 |
| 23 |
| EG001 | Twice Daily Regimen | Twice daily medication regimen (Tacrolimus and mycophenolic acid) Twice daily immunosuppression regimen: This is the arm which we are designating the standard, which will be the comparison to the active drug arm. | 0 | 24 | 13 | 24 | 1 | 24 |
| Infection | Infections and infestations | Systematic Assessment |
|
| Urine leak | Renal and urinary disorders | Systematic Assessment |
|
| Hyperkalemia | General disorders | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nausea and vomiting/abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Transplant renal artery stenosis | Vascular disorders | Systematic Assessment |
|
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