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
2016
A critical assessment on kidney allocation systems
Formica RN. A critical assessment on kidney allocation systems. Transplantation Reviews 2016, 31: 61-67. PMID: 27919635, DOI: 10.1016/j.trre.2016.10.002.Peer-Reviewed Original ResearchConceptsKidney allocation systemKidney allocationKidney Donor Profile IndexNew kidney allocation systemDelayed graft functionCold ischemic timeDeceased donor kidneysNumber of transplantsOrgan procurement organizationsGraft functionKidney transplantationIschemic timeDonor kidneysTransplant centersOrgan discard ratesClose monitoringMedical needKidneyProcurement organizationsPatientsTransplantationAllocation systemLife savingSignificant declineProfile indexEculizumab 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 changeThe Long‐Term Follow‐up and Support for Living Organ Donors: A Center‐Based Initiative Founded on Developing a Community of Living Donors
Kulkarni S, Thiessen C, Formica RN, Schilsky M, Mulligan D, D'Aquila R. The Long‐Term Follow‐up and Support for Living Organ Donors: A Center‐Based Initiative Founded on Developing a Community of Living Donors. American Journal Of Transplantation 2016, 16: 3385-3391. PMID: 27500361, DOI: 10.1111/ajt.14005.Peer-Reviewed Original ResearchSimultaneous 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
Interferon 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 age
2013
Written Informed Consent for Living Kidney Donors: Practices and Compliance With CMS and OPTN Requirements
Thiessen C, Kim YA, Formica R, Bia M, Kulkarni S. Written Informed Consent for Living Kidney Donors: Practices and Compliance With CMS and OPTN Requirements. American Journal Of Transplantation 2013, 13: 2713-2721. PMID: 24020884, DOI: 10.1111/ajt.12406.Peer-Reviewed Original ResearchConceptsConsent formKidney donorsKidney donor evaluationLiving Kidney DonorsKidney transplantRoutine followTransplant centersDonor evaluationUS CentersOPTN policyOrgan procurementHealth problemsInformed consentInformed consent practicesPrior yearSurgeryDonor consentConsentConsent practicesDonorsComplicationsTransplantComplianceFollowYearsMulticenter 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
2011
Multidetector CT angiography in living donor renal transplantation: accuracy and discrepancies in right venous anatomy
Kulkarni S, Emre S, Arvelakis A, Asch W, Bia M, Formica R, Israel G. Multidetector CT angiography in living donor renal transplantation: accuracy and discrepancies in right venous anatomy. Clinical Transplantation 2011, 25: 77-82. PMID: 20070320, DOI: 10.1111/j.1399-0012.2009.01193.x.Peer-Reviewed Original ResearchConceptsVenous anatomyVenous phaseMDCT angiographyRenal anatomyCircumaortic renal veinDonor renal transplantationEarly arterial bifurcationLate venous confluenceMultiple arterial anomaliesRight donor nephrectomyIntra-operative findingsMultiple venous anomaliesContrast-enhanced phasesArterial anomaliesRetroaortic veinRenal transplantationDonor nephrectomyMultiple arteriesVenous anomaliesRenal veinVenous confluenceKidney donorsTomography angiographyAnatomical variantsDonor anatomy
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