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
Utility 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
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 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
Multicenter 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
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