Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR
NCT ID: NCT04773392
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
20 participants
INTERVENTIONAL
2021-11-23
2024-02-23
Brief Summary
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Detailed Description
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Immediate release (IR) tacrolimus based immunosuppressive regimens have become the standard of care at most US centers. With the introduction of a once-daily tacrolimus formulation, kidney transplant recipients can now be on a combination regimen (EnvarsusXR and azathioprine) that permits all immunosuppressive medications to be taken once a day instead of twice . Previous studies suggest that therapeutic goals with EnvarsusXR may be achieved at a lower dose than the currently recommended dose. This once a day medication schedule has the potential to simplify the immunosuppressive regimen by reducing adverse side effects and facilitating compliance.
The investigators seek to demonstrate that a once-daily regimen, including EnvarsusXR and azathioprine, will be at least equally effective with respect to acute rejection, graft and patient survival as compared to the standard, twice-daily, immediate release tacrolimus and mycophenolate mofetil/mycophenolic acid. The investigators will also assess graft function, medication complications and side effects in each arm.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Twice-daily Regimen
Twice-daily regimen of immediate release tacrolimus, mycophenolate mofetil (MMF)/mycophenolic acid (MPA) plus daily methylprednisolone or prednisone.
Twice-daily Tacrolimus
Within 48 hours of transplantation, immediate release tacrolimus (IRT) (0.1 mg/kg /day) will be administered twice a day.
Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG)
Induction immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG) per protocol. The dose of Basiliximab will be a standard of two 20 mg doses and total rATG will not exceed 6 mg/kg.
Methylprednisolone, prednisone
Methylprednisolone intraoperatively (500mg) and immediately post transplantation (200mg on post operative day (POD) #1, 150mg on POD#2, 100mg on POD#3) then oral prednisone (50mg on POD #4, 20mg on POD #5). Oral prednisone will be tapered down to a minimal dose of 5mg within 6 weeks post transplantation.
Mycophenolate mofetil (MMF) or Mycophenolic acid (MPA)
Mycophenolate mofetil (MMF) (up to 1000mg) or Mycophenolic acid (MPA) (up to 720mg) will be administered twice a day.
Once-daily Regimen
Once-daily regimen of Envarsus, azathioprine plus methylprednisolone or prednisone.
Once-daily envarsus XR
Within 48 hours of transplantation, Envarsus XR (0.13mg/kg/day) will be administered once a day.
Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG)
Induction immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG) per protocol. The dose of Basiliximab will be a standard of two 20 mg doses and total rATG will not exceed 6 mg/kg.
Methylprednisolone, prednisone
Methylprednisolone intraoperatively (500mg) and immediately post transplantation (200mg on post operative day (POD) #1, 150mg on POD#2, 100mg on POD#3) then oral prednisone (50mg on POD #4, 20mg on POD #5). Oral prednisone will be tapered down to a minimal dose of 5mg within 6 weeks post transplantation.
Azathioprine
Azathioprine (1-3 mg/kg) will be administered once a day.
Interventions
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Twice-daily Tacrolimus
Within 48 hours of transplantation, immediate release tacrolimus (IRT) (0.1 mg/kg /day) will be administered twice a day.
Once-daily envarsus XR
Within 48 hours of transplantation, Envarsus XR (0.13mg/kg/day) will be administered once a day.
Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG)
Induction immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG) per protocol. The dose of Basiliximab will be a standard of two 20 mg doses and total rATG will not exceed 6 mg/kg.
Methylprednisolone, prednisone
Methylprednisolone intraoperatively (500mg) and immediately post transplantation (200mg on post operative day (POD) #1, 150mg on POD#2, 100mg on POD#3) then oral prednisone (50mg on POD #4, 20mg on POD #5). Oral prednisone will be tapered down to a minimal dose of 5mg within 6 weeks post transplantation.
Mycophenolate mofetil (MMF) or Mycophenolic acid (MPA)
Mycophenolate mofetil (MMF) (up to 1000mg) or Mycophenolic acid (MPA) (up to 720mg) will be administered twice a day.
Azathioprine
Azathioprine (1-3 mg/kg) will be administered once a day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cold ischemia time (CIT) \< 24 hours for 3-6 HLA mismatches between donor and recipient and CIT \>24 hours for HLA mismatch of less than 3 between donor and recipient
* Most recent pre-transplant cPRA (calculated panel reactive antibody) ≤ 20%
Exclusion Criteria
* cPRA \>20%
* rATG (rabbit anti-thymocyte globulin) induction \>6mg/kg at time of induction
* Crossmatches deemed positive by accepting physician
* Presence of pre-formed anti-HLA (anti-Human Leukocyte Antigen) DSA (Donor-Specific Antibody) as defined by MFI (mean fluorescence intensity) approaching 3000 using flow cytometry/Luminex-based, specific anti-HLA antibody testing.
* Receipt of desensitization protocols
* History of skin cancer
* Recipient of multi-organ or dual kidney transplants
* For any condition, in which the investigator's opinion makes the subject unsuitable for study
18 Years
85 Years
ALL
No
Sponsors
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Veloxis Pharmaceuticals
INDUSTRY
University of Southern California
OTHER
Responsible Party
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Santhi Voora
Assistant Professor
Principal Investigators
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Santhi Voora, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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University of Southern California
Los Angeles, California, United States
Countries
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References
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Park SI, Felipe CR, Pinheiro-Machado PG, Garcia R, Fernandes FB, Casarini DE, Tedesco-Silva H Jr, Medina-Pestana JO. Tacrolimus pharmacokinetic drug interactions: effect of prednisone, mycophenolic acid or sirolimus. Fundam Clin Pharmacol. 2009 Feb;23(1):137-45. doi: 10.1111/j.1472-8206.2008.00644.x.
Dalal P, Shah G, Chhabra D, Gallon L. Role of tacrolimus combination therapy with mycophenolate mofetil in the prevention of organ rejection in kidney transplant patients. Int J Nephrol Renovasc Dis. 2010;3:107-15. doi: 10.2147/ijnrd.s7044. Epub 2010 Aug 4.
Kulich KR, Madisch A, Pacini F, Pique JM, Regula J, Van Rensburg CJ, Ujszaszy L, Carlsson J, Halling K, Wiklund IK. Reliability and validity of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire in dyspepsia: a six-country study. Health Qual Life Outcomes. 2008 Jan 31;6:12. doi: 10.1186/1477-7525-6-12.
Troster AI, Pahwa R, Fields JA, Tanner CM, Lyons KE. Quality of life in Essential Tremor Questionnaire (QUEST): development and initial validation. Parkinsonism Relat Disord. 2005 Sep;11(6):367-73. doi: 10.1016/j.parkreldis.2005.05.009.
Related Links
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Prescribing information
Other Identifiers
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HS-18-00513
Identifier Type: -
Identifier Source: org_study_id