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
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
Association Between Organ Procurement Organization Social Network Centrality and Kidney Discard and Transplant Outcomes
Butala NM, King MD, Reitsma W, Formica RN, Abt PL, Reese PP, Parikh CR. Association Between Organ Procurement Organization Social Network Centrality and Kidney Discard and Transplant Outcomes. Transplantation 2015, 99: 2617-2624. PMID: 26102610, PMCID: PMC4668206, DOI: 10.1097/tp.0000000000000773.Peer-Reviewed Original ResearchConceptsKidney volumeKidney Donor Risk IndexLower kidney volumesDelayed graft functionDonor risk indexKidney transplant waitlistCold ischemia timeDeceased donor kidneysHigher kidney volumeGraft functionGraft lossTransplant recipientsOrgan acceptanceTransplant outcomesDonor kidneysPrimary outcomeWaitlist timeRecipient outcomesScientific RegistryPrimary exposureTransplant waitlistKidney discardMultivariable regressionTransplant NetworkKidneyInterferon 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
Cytomegalovirus Glomerulopathy and Cytomegalovirus Interstitial Nephritis on Sequential Transplant Kidney Biopsies
Vichot AA, Formica RN, Moeckel GW. Cytomegalovirus Glomerulopathy and Cytomegalovirus Interstitial Nephritis on Sequential Transplant Kidney Biopsies. American Journal Of Kidney Diseases 2013, 63: 536-539. PMID: 24568687, PMCID: PMC7210789, DOI: 10.1053/j.ajkd.2013.08.021.Peer-Reviewed Original ResearchConceptsSecond biopsy specimenBiopsy specimenCMV infectionInterstitial nephritisKidney biopsyKidney transplant biopsy specimensEndothelial cellsCMV-negative patientsCMV-positive cellsCMV-positive donorsFirst biopsy specimenKidney transplant graftsSequential kidney biopsiesTransplant biopsy specimensTransplant kidney biopsiesGlomerular capillary endothelial cellsTubular epithelial cellsGlomerular capillary loopsGlomerular capillary luminaCapillary endothelial cellsCytoplasmic viral particlesKidney transplantTubular injuryLymphoplasmacytic infiltrateTransplant graftsWritten 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
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
2006
A randomized trial comparing losartan with amlodipine as initial therapy for hypertension in the early post-transplant period
Formica RN, Friedman AL, Lorber MI, Smith JD, Eisen T, Bia MJ. A randomized trial comparing losartan with amlodipine as initial therapy for hypertension in the early post-transplant period. Nephrology Dialysis Transplantation 2006, 21: 1389-1394. PMID: 16431893, DOI: 10.1093/ndt/gfk058.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAmlodipineBlood Pressure DeterminationChi-Square DistributionDose-Response Relationship, DrugDrug Administration ScheduleFemaleFollow-Up StudiesHumansHypertensionKidney Failure, ChronicKidney TransplantationLosartanMaleMiddle AgedProbabilityRisk AssessmentSeverity of Illness IndexTreatment OutcomeConceptsRenal transplant recipientsPost-transplant periodEarly post-transplant periodARB useUse of ARBInitial therapyCCB groupImmediate post-transplant periodPost-transplant erythrocytosisPost-transplant hypertensionRisk of hyperkalaemiaPost-transplant managementSerum creatinine levelsChronic kidney diseaseII receptor blockersCalcium channel blockersNumber of patientsAldosterone systemARB groupKidney transplantationRenal transplantationTransplant recipientsCreatinine levelsRenal functionBlood pressure