2024
Use of LCP-Tacrolimus (LCPT) in Kidney Transplantation: A Delphi Consensus Survey of Expert Clinicians
Wiseman A, Alhamad T, Alloway R, Concepcion B, Cooper M, Formica R, Klein C, Kumar V, Leca N, Shihab F, Taber D, Mulnick S, Bushnell D, Hadi M, Bunnapradist S. Use of LCP-Tacrolimus (LCPT) in Kidney Transplantation: A Delphi Consensus Survey of Expert Clinicians. Annals Of Transplantation 2024, 29: e943498-1-e943498-13. PMID: 38526543, PMCID: PMC10944009, DOI: 10.12659/aot.943498.Peer-Reviewed Original ResearchConceptsLCP-tacrolimusImmediate-release tacrolimusKidney transplantationFirst-line optionKidney transplant recipientsRandomized clinical trialsDe novo settingTacrolimus formulationReview available dataEvidence-based recommendationsTrough levelsOnce-dailyTransplant recipientsClinical decision-makingOptimal doseClinical trialsExpert cliniciansConsensus statementTransplant expertsStrength of evidenceClinical practiceKidneyTacrolimusDe novoDelphi consensus survey
2015
Switching STudy of Kidney TRansplant PAtients with Tremor to LCP‐TacrO (STRATO): an open‐label, multicenter, prospective phase 3b study
Langone A, Steinberg S, Gedaly R, Chan L, Shah T, Sethi K, Nigro V, Morgan J, , Formica R, Barr Y, Brennan D, El‐Amm J, Kozlowski T, Matas A, West‐Thielke P, Kistler K. Switching STudy of Kidney TRansplant PAtients with Tremor to LCP‐TacrO (STRATO): an open‐label, multicenter, prospective phase 3b study. Clinical Transplantation 2015, 29: 796-805. PMID: 26113208, PMCID: PMC4755036, DOI: 10.1111/ctr.12581.Peer-Reviewed Original ResearchConceptsKidney transplant recipientsPhase 3b studyDose reductionKidney transplant patientsPatient Global ImpressionCommon side effectsImmediate-release tacrolimusExtended-release formulationMovement disorder neurologistsFurther dose reductionTransplant recipientsMITT populationStable doseTransplant patientsGlobal ImpressionMarin scaleFahn-TolosaAUC exposureSide effectsPatientsTacrolimusMeaningful improvementsDrug concentrationsSignificant tremorTremorAdverse Outcomes of Tacrolimus Withdrawal in Immune–Quiescent Kidney Transplant Recipients
Hricik DE, Formica RN, Nickerson P, Rush D, Fairchild RL, Poggio ED, Gibson IW, Wiebe C, Tinckam K, Bunnapradist S, Samaniego-Picota M, Brennan DC, Schröppel B, Gaber O, Armstrong B, Ikle D, Diop H, Bridges ND, Heeger PS. Adverse Outcomes of Tacrolimus Withdrawal in Immune–Quiescent Kidney Transplant Recipients. Journal Of The American Society Of Nephrology 2015, 26: 3114-3122. PMID: 25925687, PMCID: PMC4657844, DOI: 10.1681/asn.2014121234.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodiesAtrophyCalcineurin InhibitorsChemokine CXCL9Early Termination of Clinical TrialsFemaleFibrosisGraft RejectionHistocompatibility TestingHLA-DQ AntigensHumansImmunosuppression TherapyInterferon-gammaKidneyKidney TransplantationKidney TubulesMaleMiddle AgedNephritisProspective StudiesTacrolimusWithholding TreatmentYoung AdultConceptsDe novo donor-specific antibodiesKidney transplant recipientsAcute rejectionTransplant recipientsCNI withdrawalEpitope mismatchesTacrolimus withdrawalProtocol biopsiesCalcineurin inhibitorsDe novo DSADevelopment of dnDSANovo donor-specific antibodiesRabbit antithymocyte globulinTubular atrophy scoreDonor-specific antibodiesPrimary end pointIFN-γ ELISPOTDonor kidney transplantsUnacceptable rateAntithymocyte globulinCare immunosuppressionUrinary CXCL9Withdrawal armMycophenolate mofetilKidney transplant
2013
Clinical outcomes associated with conversion from brand-name to generic tacrolimus in hospitalized kidney transplant recipients
Heavner MS, Tichy EM, Yazdi M, Formica RN, Kulkarni S, Emre S. Clinical outcomes associated with conversion from brand-name to generic tacrolimus in hospitalized kidney transplant recipients. American Journal Of Health-System Pharmacy 2013, 70: 1507-1512. PMID: 23943182, DOI: 10.2146/ajhp120783.Peer-Reviewed Original ResearchConceptsKidney transplant recipientsBrand-name tacrolimusTrough tacrolimus levelsTransitions of careTransplant recipientsAcute rejectionTacrolimus levelsTacrolimus dosageHospital admissionBiopsy-proven acute rejectionSingle-center observational studyTacrolimus trough levelsMonths of dischargePercentage of patientsMeeting study criteriaPeriod of careGeneric tacrolimusKidney transplantTrough concentrationsTrough levelsClinical outcomesDosage adjustmentGeneric formulationStudy criteriaObservational study