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12 March 2024: Original Paper

Use of LCP-Tacrolimus (LCPT) in Kidney Transplantation: A Delphi Consensus Survey of Expert Clinicians

Alexander Wiseman 1ADEF* , Tarek Alhamad 2DE , Rita R. Alloway 3DEF , Beatrice P. Concepcion 4DE , Matthew Cooper 5DE , Richard Formica 6DE , Christina L. Klein 7DE , Vineeta Kumar 8DEF , Nicolae Leca 9DE , Fuad Shihab 10DE , David J. Taber 11DE , Sarah Mulnick 12ABCDE , Donald M. Bushnell 12BCDE , Monica Hadi 13ABCDE , Suphamai Bunnapradist 14ADEF

DOI: 10.12659/AOT.943498

Ann Transplant 2024; 29:e943498

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Table 3 Delphi statement progression, LCPT (Envarsus XR®) use in a de novo setting.

Original statement for consensus*Status Round 1Action Round 2Final statusaFinal consensusFinal statement*
1. In the de novo setting, Envarsus XR can be used as first-line therapy considering its efficacy and safety are equivalent to BID tacrolimus. A. similar efficacy (biopsy-proven acute rejection (BPAR) and graft survival at 12 months B. similar safety profileConsensusConsensus after R192%In the de novo setting, Envarsus XR can be used as first-line therapy considering its efficacy and safety are equivalent to BID tacrolimus. A. Envarsus XR has a similar efficacy profile as tacrolimus IR B. Envarsus XR has a similar safety profile as tacrolimus IR
2. When considering safety and efficacy, Envarsus XR is not recommended as first-line therapy in patients with significant pre-existing GI motility issues in the de novo settingb No consensusNo further revisions due to very low consensus, low to moderate perceived strength of evidence and alignment with clinical practiceDropped after Round 141%N/A
3. When considering safety and efficacy, Envarsus XR is preferred as first-line therapy for African American patient population in the de novo settingConsensusConsensus after R183%. When considering safety and efficacy, Envarsus XR is preferred as first-line therapy for African American patient population in the de novo setting
4. When considering safety and efficacy, Envarsus XR is preferred as first-line therapy for elderly patient population in the de novo setting.No consensusNo further revisions due to low consensus, a lack of supporting evidence and low-to-moderate alignment with clinical practiceDropped after Round 158%N/A
5. When considering safety and efficacy, Envarsus XR is preferred as first-line therapy in known rapid metabolizers in the de novo settingConsensusConsensus after R191%. When considering safety and efficacy, Envarsus XR is preferred as first-line therapy as first-line therapy in known rapid metabolizers in the de novo setting
6. When considering safety and efficacy, Envarsus XR is preferred as first-line therapy in patients with high immunologic risk in the de novo settingNo consensusNo further revisions due to to very low consensus, low perceived strength of evidence and moderate alignment with clinical practiceDropped after Round 125%N/A
7. In the de novo setting, the first assessment of trough levels of Envarsus XR be after the third doseNo consensusStatement revised for consensus in Round 2Consensus after R292%In the de novo setting, the first assessment of trough levels of Envarsus XR be after the third dose
8. In the de novo setting, the Envarsus XR dosing should begin with 0.14 mg/kg/dayNo consensusStatement revised for consensus in Round 2Consensus after R2b (email round)92%In the de novo setting, the Envarsus XR dosing should begin with 0.14 mg/kg/dayc
8a. In the de novo setting, ideal body weight should be used as the preferred initial dosing weight for Envarsus XR in obese recipientsConsensusConsensus after R1100%In the de novo setting, ideal body weight should be used as the preferred initial dosing weight for Envarsus XR in obese recipients
9. In the de novo setting, Envarsus XR should be initiated on the morning of POD1 for all kidney transplant recipients, regardless of initial kidney functionConsensusConsensus after R183%In the de novo setting, Envarsus XR should be initiated on the morning of POD1 for all kidney transplant recipients, regardless of initial kidney function
10. In the de novo setting, initial dosing of Envarsus XR can be reduced in the setting of depleting antibody therapy when using induction therapyConsensusConsensus after R183%In the de novo setting, initial dosing of Envarsus XR can be reduced in the setting of depleting antibody therapy when using induction therapy
11. In the de novo setting, initial dosing of Envarsus XR can be in patients for whom the risk of supratherapeutic levels outweighs the benefit of rapid achievement of therapeutic levels ()No consensusStatement revised for consensus in Round 2Consensus after R2100%In the de novo setting, initial dosing of Envarsus XR can be in patients for whom the risk of supratherapeutic levels outweighs the benefit of rapid achievement of therapeutic levels
12. During the first week post-transplant the dose of Envarsus XR should only be adjusted in circumstances of a supratherapeutic level or circumstances of a significantly subtherapeutic trough level suggestive of rapid metabolism (e.g., tacrolimus troughConsensusConsensus after R175%During the first week post-transplant the dose of Envarsus XR should only be adjusted in circumstances of a supratherapeutic level or circumstances of a significantly subtherapeutic trough level suggestive of rapid metabolism (e.g., tacrolimus trough
13. Conversion to Envarsus XR is recommended to address neurological side-effects related to BID TacrolimusConsensusConsensus after R1100%Conversion to Envarsus XR is recommended to address neurological side-effects related to BID Tacrolimus
14. Steady state is achieved after Envarsus XR dose 7 and therefore, on a stable dose, dose adjustments can be made per clinical practice protocols following the seventh doseConsensusConsensus after R175%Steady state is achieved after Envarsus XR dose 7 and therefore, on a stable dose, dose adjustments can be made per clinical practice protocols following the seventh dose
15. Further evidence of clinical long-term outcomes (graft survival, renal function) support the use of Envarsus XR current clinical practice, in both the de novo setting and conversion settingNo consensusStatement revised for consensus in Round 2Consensus after R292%Further evidence of clinical long-term outcomes (graft survival, renal function) support the use of Envarsus XR in current clinical practice, in both the de novo setting and conversion setting
BID – twice a day; GI – gastrointestinal; POD1 – post-operative day 1.
a Consensus was set at ≥75% (at least 9 of the 12 panelists). Final consensus was agreed by all 12 panelists;
b No further revisions due to very low consensus, low-to-moderate perceived strength of evidence, and lack of alignment with clinical practice;
c Consensus was achieved after 1 round of e-mails after round 2 for this statement only.
* in an original statement for consensus indicates wording that has been altered or deleted. in a final statement indicates wording that has been altered or added.
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Annals of Transplantation eISSN: 2329-0358
Annals of Transplantation eISSN: 2329-0358