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 costRecipientsSurvivalDrugsSafety, pharmacokinetics, and pharmacodynamic activity of obinutuzumab, a type 2 anti-CD20 monoclonal antibody for the desensitization of candidates for renal transplant
Redfield RR, Jordan SC, Busque S, Vincenti F, Woodle ES, Desai N, Reed EF, Tremblay S, Zachary AA, Vo AA, Formica R, Schindler T, Tran H, Looney C, Jamois C, Green C, Morimoto A, Rajwanshi R, Schroeder A, Cascino MD, Brunetta P, Borie D. Safety, pharmacokinetics, and pharmacodynamic activity of obinutuzumab, a type 2 anti-CD20 monoclonal antibody for the desensitization of candidates for renal transplant. American Journal Of Transplantation 2019, 19: 3035-3045. PMID: 31257724, PMCID: PMC6899639, DOI: 10.1111/ajt.15514.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAntibodies, Monoclonal, HumanizedAntigens, CD20Antineoplastic Agents, ImmunologicalCohort StudiesDesensitization, ImmunologicFemaleFollow-Up StudiesGraft SurvivalHLA AntigensHumansKidney Failure, ChronicKidney TransplantationMaleMaximum Tolerated DoseMiddle AgedPatient SelectionPrognosisRisk FactorsTissue DistributionYoung AdultConceptsB-cell depletionSerious adverse eventsIntravenous immunoglobulinCell depletionAdverse eventsOpen-label phase 1b studyType 2Doses of IVIGIncomplete B cell depletionPanel reactive antibody scorePeripheral B-cell depletionEnd-stage renal diseasePhase 1b studyAnti-HLA antibodiesRetroperitoneal lymph nodesSingle antigen beadsTime of transplantCD20 monoclonal antibodyMedian followRenal transplantKidney transplantMost patientsWeek 24Lymph nodesRenal disease
2018
Analysis of Biomarkers Within the Initial 2 Years Posttransplant and 5-Year Kidney Transplant Outcomes
Faddoul G, Nadkarni GN, Bridges ND, Goebel J, Hricik DE, Formica R, Menon MC, Morrison Y, Murphy B, Newell K, Nickerson P, Poggio ED, Rush D, Heeger PS. Analysis of Biomarkers Within the Initial 2 Years Posttransplant and 5-Year Kidney Transplant Outcomes. Transplantation 2018, 102: 673-680. PMID: 29189482, PMCID: PMC6018026, DOI: 10.1097/tp.0000000000002026.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBiomarkersChemokine CXCL9Enzyme-Linked Immunospot AssayFemaleGlomerular Filtration RateGraft RejectionGraft SurvivalHumansInterferon-gammaInterferon-gamma Release TestsKidneyKidney TransplantationMaleMiddle AgedNorth AmericaPredictive Value of TestsProspective StudiesRisk FactorsTime FactorsTreatment OutcomeConceptsEnzyme-linked immunosorbent spotGraft lossAcute cellular rejectionKidney allograft lossKidney transplant outcomesGlomerular filtration rateMultivariable logistic regressionAllograft lossCellular rejectionCXCL9 levelsUrinary CXCL9Year posttransplantTransplant outcomesImmunosorbent spotUnivariable analysisChemokine measurementsFiltration rateSurrogate markerClinical trialsLate outcomesOrgan transplantationT cellsInterferon gammaAnalysis of biomarkersLogistic regression
2017
Transition probabilities between changing sensitization levels, waitlist activity status and competing-risk kidney transplant outcomes using multi-state modeling
Kulkarni S, Hall I, Formica R, Thiessen C, Stewart D, Gan G, Greene E, Deng Y. Transition probabilities between changing sensitization levels, waitlist activity status and competing-risk kidney transplant outcomes using multi-state modeling. PLOS ONE 2017, 12: e0190277. PMID: 29287087, PMCID: PMC5747475, DOI: 10.1371/journal.pone.0190277.Peer-Reviewed Original ResearchConceptsTransplant probabilityTransplant outcomesActivity statusKidney transplant outcomesKAS implementationPost-KASWaitlist mortalityPatient characteristicsOPTN databaseMulti-state modelingStatistical differenceSensitization levelOutcomesTransplantCohortImpact outcomesCPRAStatus combinationsStatusMortalityWhitesSensitizationUtility of Applying Quality Assessment Tools for Kidneys With KDPI ≥80
Doshi MD, Reese PP, Hall IE, Schröppel B, Ficek J, Formica RN, Weng FL, Hasz RD, Thiessen-Philbrook H, Parikh C. Utility of Applying Quality Assessment Tools for Kidneys With KDPI ≥80. Transplantation 2017, 101: 1125-1133. PMID: 27490414, PMCID: PMC5290306, DOI: 10.1097/tp.0000000000001388.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBiomarkersBiopsyDecision Support TechniquesDonor SelectionFemaleGraft SurvivalHumansKaplan-Meier EstimateKidneyKidney TransplantationMaleMiddle AgedPredictive Value of TestsProcess Assessment, Health CareProspective StudiesQuality Indicators, Health CareRisk AssessmentRisk FactorsTissue DonorsTissue SurvivalTreatment OutcomeUnited StatesConceptsKidney Donor Profile IndexGroup 1High kidney donor profile indexDonor kidney poolViability of kidneysGlomerular filtration rateOutcomes of kidneysNumber of kidneysQuality assessment toolKidney poolViable kidneysBiopsy findingsGraft failureRenal resistanceDeceased donorsMulticenter studyFiltration rateBiomarker levelsGroup 3Kidney abnormalitiesKidneySignificant differencesHigh rateAssessment toolProfile index
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 changeIntegrase strand transferase inhibitors: the preferred antiretroviral regimen in HIV-positive renal transplantation
Azar MM, Malinis MF, Moss J, Formica RN, Villanueva MS. Integrase strand transferase inhibitors: the preferred antiretroviral regimen in HIV-positive renal transplantation. International Journal Of STD & AIDS 2016, 28: 447-458. PMID: 27193421, DOI: 10.1177/0956462416651528.Peer-Reviewed Original ResearchConceptsInhibitor-based regimensRenal transplantationHIV/AIDSAntiretroviral regimenAntiretroviral therapyGraft survivalHIV-positive renal transplant recipientsEnd-stage renal diseaseHIV-positive patientsRenal transplant recipientsChronic kidney diseaseThree-year survivalInhibitor-based therapyNon-nucleoside reverseDrug-drug interactionsTransferase inhibitorsImmunosuppressive medicationsKidney transplantationTransplant recipientsAllograft rejectionGraft failureRenal diseaseCalcineurin inhibitorsClinical outcomesImmunosuppressive drugsChanges in Deceased Donor Kidney Transplantation One Year After KAS Implementation
Stewart DE, Kucheryavaya AY, Klassen DK, Turgeon NA, Formica RN, Aeder MI. Changes in Deceased Donor Kidney Transplantation One Year After KAS Implementation. American Journal Of Transplantation 2016, 16: 1834-1847. PMID: 26932731, DOI: 10.1111/ajt.13770.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedCadaverChildChild, PreschoolDelayed Graft FunctionDonor SelectionFemaleGovernment RegulationGraft SurvivalHealth Plan ImplementationHumansInfantInfant, NewbornKidney TransplantationMaleMiddle AgedRetrospective StudiesTime FactorsTissue and Organ ProcurementTissue DonorsUnited StatesYoung AdultConceptsKidney allocation systemDelayed graft function ratesNew kidney allocation systemGraft function rateGraft survival ratesCold ischemic timeKAS implementationLongevity matchingRecipient ageIschemic timeDonor kidneysSubsequent taperingFunction rateRecipient characteristicsOrgan procurementSurvival rateTransplantOne-yearBolus effectRecipientsKidneyDialysisExtended durationEarly impactYearsSimultaneous Liver–Kidney Allocation Policy: A Proposal to Optimize Appropriate Utilization of Scarce Resources
Formica R, Aeder M, Boyle G, Kucheryavaya A, Stewart D, Hirose R, Mulligan D. Simultaneous Liver–Kidney Allocation Policy: A Proposal to Optimize Appropriate Utilization of Scarce Resources. American Journal Of Transplantation 2016, 16: 758-766. PMID: 26603142, DOI: 10.1111/ajt.13631.Peer-Reviewed Original ResearchConceptsMayo End-Stage Liver Disease (MELD) scoreEnd-stage liver disease (MELD) scoreSimultaneous liver-kidney transplantKidney Donor Profile IndexConcurrent kidney transplantsLiver-kidney transplantLiver Disease scoreMedical Eligibility CriteriaLiver allocation policyOPTN Final RulePediatric recipientsKidney transplantRenal functionRenal insufficiencyUnited NetworkLiver candidatesTransplant communityDisease scoreOrgan donorsEligibility criteriaOrgan procurementTransplantation NetworkFinal ruleKidney allocationYoung adults
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 ageAdverse 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
2012
A One-Day Centralized Work-up for Kidney Transplant Recipient Candidates: A Quality Improvement Report
Formica RN, Barrantes F, Asch WS, Bia MJ, Coca S, Kalyesubula R, McCloskey B, Leary T, Arvelakis A, Kulkarni S. A One-Day Centralized Work-up for Kidney Transplant Recipient Candidates: A Quality Improvement Report. American Journal Of Kidney Diseases 2012, 60: 288-294. PMID: 22571868, DOI: 10.1053/j.ajkd.2012.04.008.Peer-Reviewed Original ResearchConceptsKidney transplantImprovement reportMultivariable Cox proportional hazards modelsCox proportional hazards modelKidney transplant candidacyMinimal listing criteriaGroup of patientsUniversity-based hospitalQuality improvement reportProportional hazards modelTransplant candidacyTransplant evaluationUNOS waitlistWaitlist placementTransplant centersComorbid conditionsMedian timeMultivariable analysisTransplant practitionersDialysis exposureFunctional statusWait listHazards modelPatientsRecipient candidatesAn analysis of measured and estimated creatinine clearance rates in normal weight, overweight, and obese patients with gynecologic cancers
Nelson WK, Formica RN, Cooper DL, Schwartz PE, Rutherford TJ. An analysis of measured and estimated creatinine clearance rates in normal weight, overweight, and obese patients with gynecologic cancers. Journal Of Oncology Pharmacy Practice 2012, 18: 323-332. PMID: 22331238, DOI: 10.1177/1078155211435714.Peer-Reviewed Original Research
2011
Combined Liver Kidney Transplantation: Critical Analysis of a Single-Center Experience
Cimsit B, Schilsky M, Moini M, Cartiera K, Arvelakis A, Kulkarni S, Formica R, Caldwell C, Taddei T, Asch W, Emre S. Combined Liver Kidney Transplantation: Critical Analysis of a Single-Center Experience. Transplantation Proceedings 2011, 43: 901-904. PMID: 21486624, DOI: 10.1016/j.transproceed.2011.02.033.Peer-Reviewed Original ResearchConceptsLiver-kidney transplantationHigh MELD scoreKidney transplantationMELD scoreKidney diseaseEnd-stage liver disease (MELD) scoreCombined liver-kidney transplantationGraft/patient survivalLow glomerular filtration rateOrgan allocation algorithmsPrimary biliary sclerosisRecurrence of HCVSevere HCV recurrenceTransplantation of patientsLiver Disease scoreSerum creatinine levelsRenal allograft rejectionSingle-center experienceGlomerular filtration rateHepatitis C virusPolycystic kidney diseaseBiliary sclerosisHCV recurrenceIschemic hepatitisOLT patients
2010
Accepting a donor kidney: an evaluation of patients’ and transplant surgeons’ priorities
Solomon DA, Rabidou N, Kulkarni S, Formica R, Fraenkel L. Accepting a donor kidney: an evaluation of patients’ and transplant surgeons’ priorities. Clinical Transplantation 2010, 25: 786-793. PMID: 20964716, PMCID: PMC4846340, DOI: 10.1111/j.1399-0012.2010.01342.x.Peer-Reviewed Original ResearchConceptsKidney qualityDonor kidneysTransplant surgeonsEvaluation of patientsMann-Whitney U testTransplant outcomesPatient characteristicsSpearman correlation coefficientPatient prioritiesWaiting listPatientsAvailable kidneysClinical practiceSurgeon rankingsKidneyU testSurgeonsCategorical variablesPatient autonomyComputer surveyCorrelation coefficientTransplantationFactorsGreat value
2009
HCV Response in Patients With End Stage Renal Disease Treated With Combination Pegylated Interferon α-2a and Ribavirin
Hakim W, Sheikh S, Inayat I, Caldwell C, Smith D, Lorber M, Friedman A, Jain D, Bia M, Formica R, Mehal W. HCV Response in Patients With End Stage Renal Disease Treated With Combination Pegylated Interferon α-2a and Ribavirin. Journal Of Clinical Gastroenterology 2009, 43: 477-481. PMID: 19142165, PMCID: PMC3715868, DOI: 10.1097/mcg.0b013e318180803a.Peer-Reviewed Original ResearchConceptsEnd-stage renal diseaseHepatitis C virusCombination therapyRenal diseasePosttreatment rateSide effectsSerious adverse side effectsDose of ribavirinNon-ESRD patientsSafe therapeutic optionEarly virologic responseProspective observational studyMonths of treatmentStage renal diseaseCases of anemiaInitial response rateLength of treatmentInterferon α-2aAdverse side effectsPO weeklyVirologic responseESRD patientsHCV infectionESRD populationHCV response