2016
Effect of KRN23, a fully human anti-FGF23 monoclonal antibody, on rickets in children with X-linked hypophosphatemia (XLH): 40-week interim results from a randomized, open-label phase 2 study
Linglart A, Carpenter T, Imel E, Boot A, Högler W, Padidela R, Hoff W, Whyte M, Chen C, Skrinar A, Agarwal S, San Martin J, Portale A. Effect of KRN23, a fully human anti-FGF23 monoclonal antibody, on rickets in children with X-linked hypophosphatemia (XLH): 40-week interim results from a randomized, open-label phase 2 study. Annales D Endocrinologie 2016, 77: 440. DOI: 10.1016/j.ando.2016.07.547.Peer-Reviewed Original ResearchRickets Severity ScoreAdverse eventsQ2W dosingXLH childrenSerum PiMost treatment-related adverse eventsOpen-label phase 2 studyTransient injection site reactionsTreatment-related adverse eventsPhase 2 studySerious adverse eventsInjection site reactionsSerum phosphate levelsRadiographic Global ImpressionSerum Pi concentrationSerum iPTHUrine calciumRenal ultrasoundSite reactionsCare treatmentGlobal ImpressionSeverity scoreKRN23Phosphorus homeostasisShort stature
2014
Randomized trial of the anti-FGF23 antibody KRN23 in X-linked hypophosphatemia
Carpenter TO, Imel EA, Ruppe MD, Weber TJ, Klausner MA, Wooddell MM, Kawakami T, Ito T, Zhang X, Humphrey J, Insogna KL, Peacock M. Randomized trial of the anti-FGF23 antibody KRN23 in X-linked hypophosphatemia. Journal Of Clinical Investigation 2014, 124: 1587-1597. PMID: 24569459, PMCID: PMC3973088, DOI: 10.1172/jci72829.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCalciumFamilial Hypophosphatemic RicketsFemaleFibroblast Growth Factor-23Fibroblast Growth FactorsGlomerular Filtration RateHalf-LifeHumansInjections, IntravenousInjections, SubcutaneousKidney TubulesMaleMiddle AgedPhosphatesVitamin DYoung AdultConceptsTmP/GFRSerum PiParathyroid hormonePhosphate reabsorptionXLH patientsRenal tubular thresholdSerum parathyroid hormoneFavorable safety profileElevated serum FGF23Renal phosphate reabsorptionLow serum concentrationsPhosphate-regulating endopeptidaseSerum Pi concentrationFGF23 antibodySerum FGF23Dihydroxyvitamin DSafety profileTubular thresholdSingle doseSerum concentrationsKRN23Mean t1/2Potential treatmentPatientsEffect duration