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
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 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 tremorTremor
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