2019
Safety, 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
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 combinationsStatusMortalityWhitesSensitization
2016
Belatacept and Eculizumab for Treatment of Calcineurin Inhibitor-induced Thrombotic Microangiopathy After Kidney Transplantation: Case Report
Merola J, Yoo PS, Schaub J, Smith JD, Rodriguez-Davalos MI, Tichy E, Mulligan DC, Asch W, Formica R, Kashgarian M, Kulkarni S. Belatacept and Eculizumab for Treatment of Calcineurin Inhibitor-induced Thrombotic Microangiopathy After Kidney Transplantation: Case Report. Transplantation Proceedings 2016, 48: 3106-3108. PMID: 27932157, DOI: 10.1016/j.transproceed.2016.04.005.Peer-Reviewed Original ResearchConceptsCalcineurin inhibitorsHemolytic uremic syndromeThrombotic microangiopathyKidney transplantationUremic syndromeMinimization of CNIsAtypical hemolytic uremic syndromeWithdrawal of tacrolimusEarly graft lossFavorable clinical courseGraft dysfunctionGraft lossImmunosuppression strategiesUsual therapyClinical courseCase reportCTLA-4Endothelial reactionFrequent causeChallenging causeUncontrolled activationMonoclonal antibodiesCellular destructionMicroangiopathyComponent C5Eculizumab 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 changeChanges 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 impactYears
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
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 valueKidney Transplantation and HIV: Does Recipient Privacy Outweigh the Donor's Right to Information?
Formica RN, Asch WS, Wagner KR, Kulkarni S. Kidney Transplantation and HIV: Does Recipient Privacy Outweigh the Donor's Right to Information? Clinical Journal Of The American Society Of Nephrology 2010, 5: 924-928. PMID: 20203162, PMCID: PMC2863980, DOI: 10.2215/cjn.06820909.Peer-Reviewed Original ResearchConceptsHIV-positive individualsKidney transplantationMedical historyRecipient's medical historyAlternative treatment optionHIV statusKidney donorsTreatment optionsKidney donationConsensus groupTransplantationDonation procedureAbstractTextRecipient's rightRecipientsPotential donorsHealth informationPotential recipientsSpecific diseasesPanel reviewHIVDonors' rightsRiskDonorsState statues