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
2019
Economic Evaluation of Extending Medicare Immunosuppressive Drug Coverage for Kidney Transplant Recipients in the Current Era
Kadatz M, Gill JS, Gill J, Formica RN, Klarenbach S. Economic Evaluation of Extending Medicare Immunosuppressive Drug Coverage for Kidney Transplant Recipients in the Current Era. Journal Of The American Society Of Nephrology 2019, 31: 218-228. PMID: 31704739, PMCID: PMC6934999, DOI: 10.1681/asn.2019070646.Peer-Reviewed Original ResearchConceptsKidney transplant recipientsQuality-adjusted life yearsTransplant recipientsTransplant survivalDrug coverageMedicare coverageTransplant failureImmunosuppressant drugsAdditional quality-adjusted life yearCohort of MedicareMultivariable survival analysisIncremental cost-utility ratioBetter patient outcomesCost-utility ratioImmunosuppressant medicationsTransplant functionImmunosuppressive drugsPatient outcomesMedicare payersSurvival analysisLife yearsIncremental costRecipientsSurvivalDrugs
2016
Eculizumab Therapy for Chronic Antibody‐Mediated Injury in Kidney Transplant Recipients: A Pilot Randomized Controlled Trial
Kulkarni S, Kirkiles‐Smith N, Deng YH, Formica RN, Moeckel G, Broecker V, Bow L, Tomlin R, Pober JS. Eculizumab Therapy for Chronic Antibody‐Mediated Injury in Kidney Transplant Recipients: A Pilot Randomized Controlled Trial. American Journal Of Transplantation 2016, 17: 682-691. PMID: 27501352, DOI: 10.1111/ajt.14001.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAntibodies, Monoclonal, HumanizedChronic DiseaseComplement C5Complement Inactivating AgentsEarly Intervention, EducationalFemaleFollow-Up StudiesGlomerular Filtration RateGraft RejectionGraft SurvivalHumansIsoantibodiesKidney Failure, ChronicKidney Function TestsKidney TransplantationLiving DonorsMaleMiddle AgedPilot ProjectsPrognosisRisk FactorsTissue DonorsTransplant RecipientsYoung AdultConceptsDe novo donor-specific antibodiesComplement inhibitionTreatment groupsNovo donor-specific antibodiesAntibody-Mediated InjuryC1q-positive patientsDonor-specific antibodiesKidney transplant recipientsPrimary end pointEndothelial cell injuryMo of observationEculizumab therapyEculizumab treatmentHumoral injuryTransplant recipientsKidney transplantRenal functionKidney functionChronic settingEGFR trajectoriesTreatment periodCell injuryPatientsEnd pointPercentage change
2015
Duration of Prophylaxis against Fungal Infection in Kidney Transplant Recipients
Guerra CM, Formica RN, Kulkarni S, Asch WS, Tichy EM. Duration of Prophylaxis against Fungal Infection in Kidney Transplant Recipients. Progress In Transplantation 2015, 25: 311-315. PMID: 26645924, DOI: 10.7182/pit2015929.Peer-Reviewed Original ResearchConceptsKidney transplant recipientsTransplant recipientsDuration of admissionCandida esophagitisFungal infectionsAdult kidney transplant recipientsEpisodes of thrushDuration of prophylaxisRetrospective chart reviewPrimary outcome measureFisher's exact testAdministration of nystatinStudent's t-testChart reviewOutcome measuresExact testEsophagitisProphylaxisRecipientsInfectionProtocol changesT-testAdmissionTransplantP-valueSwitching 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 tremorTremorInterferon Gamma ELISPOT Testing as a Risk-Stratifying Biomarker for Kidney Transplant Injury: Results From the CTOT-01 Multicenter Study
Hricik D, Augustine J, Nickerson P, Formica R, Poggio E, Rush D, Newell K, Goebel J, Gibson I, Fairchild R, Spain K, Iklé D, Bridges N, Heeger P, consortium F. Interferon Gamma ELISPOT Testing as a Risk-Stratifying Biomarker for Kidney Transplant Injury: Results From the CTOT-01 Multicenter Study. American Journal Of Transplantation 2015, 15: 3166-3173. PMID: 26226830, PMCID: PMC4946339, DOI: 10.1111/ajt.13401.Peer-Reviewed Original ResearchMeSH KeywordsAdultAnimalsAntilymphocyte SerumBiomarkersChildEnzyme-Linked Immunosorbent AssayFemaleFollow-Up StudiesGlomerular Filtration RateGraft RejectionGraft SurvivalHumansInterferon-gammaKidney Failure, ChronicKidney Function TestsKidney TransplantationMaleMiddle AgedPostoperative ComplicationsPrognosisProspective StudiesRabbitsRisk FactorsTissue DonorsConceptsAnti-thymocyte globulinDonor-reactive memory T cellsMemory T cellsAcute rejectionPosttransplant eGFRATG inductionT cellsInterferon-gamma (IFN-gamma) enzyme-linked immunosorbent spot assaysEnzyme-linked immunosorbent spot assayBiopsy-proven acute rejectionHuman leukocyte antigen mismatchesPrimary kidney transplant recipientsRabbit anti-thymocyte globulinKidney transplant injuryKidney transplant recipientsImmunosorbent spot assayGlomerular filtration rateAfrican American racePotential effect modifiersAllograft injuryAntigen mismatchesELISPOT testingPeak PRAKidney transplantationRecipient agePsychiatric and medical adverse events for kidney transplant recipients with lithium induced kidney disease
Zimbrean P, Formica R, Ash W, Lettieri D, Kulkarni S. Psychiatric and medical adverse events for kidney transplant recipients with lithium induced kidney disease. Journal Of Psychosomatic Research 2015, 78: 634. DOI: 10.1016/j.jpsychores.2015.03.148.Peer-Reviewed Original ResearchKidney transplant recipientsMedical adverse eventsTransplant recipientsAdverse eventsKidney diseaseDiseaseRecipientsAdverse 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 studyMulticenter Validation of Urinary CXCL9 as a Risk-Stratifying Biomarker for Kidney Transplant Injury
Hricik DE, Nickerson P, Formica RN, Poggio ED, Rush D, Newell KA, Goebel J, Gibson IW, Fairchild RL, Riggs M, Spain K, Ikle D, Bridges ND, Heeger PS, consortium F. Multicenter Validation of Urinary CXCL9 as a Risk-Stratifying Biomarker for Kidney Transplant Injury. American Journal Of Transplantation 2013, 13: 2634-2644. PMID: 23968332, PMCID: PMC3959786, DOI: 10.1111/ajt.12426.Peer-Reviewed Original ResearchConceptsAcute rejectionUrinary CXCL9Kidney transplantationBiopsy-proven acute rejectionFirst kidney transplant recipientsKidney transplant injuryProgressive renal dysfunctionKidney transplant recipientsMulticenter observational studyGlomerular filtration rateAcute dysfunctionAllograft recipientsCXCL9 mRNAImmunological causesRenal dysfunctionTransplant recipientsImmune injuryTransplant injuryImmune riskUrinary mRNAFiltration rateClinical trialsObservational studyLower riskNoninvasive biomarkers
2010
Significant Sirolimus and Dronedarone Interaction in a Kidney Transplant Recipient
Tichy EM, Medwid AJ, Mills EA, Formica RN, Kulkarni S. Significant Sirolimus and Dronedarone Interaction in a Kidney Transplant Recipient. Annals Of Pharmacotherapy 2010, 44: 1338-1341. PMID: 20484171, DOI: 10.1345/aph.1p114.Peer-Reviewed Original ResearchConceptsSignificant pharmacokinetic interactionsTrough concentrationsPharmacokinetic interactionsHorn Drug Interaction Probability ScaleNarrow therapeutic index medicationsDrug Interaction Probability ScaleKidney transplant recipientsPost-kidney transplantDronedarone initiationExcessive immunosuppressionImmunosuppressive regimenIndex medicationSirolimus toxicityTransplant recipientsMycophenolate mofetilStable doseConcurrent administrationAtrial fibrillationSirolimus concentrationsBloody diarrheaTherapeutic misadventureDose reductionClose monitoringDronedaroneSirolimus