ERYTHROPOIETIN THERAPY IN DIALYSIS POPULATION

THIS PROJECT WILL RESULT IN A SHARED DATA SYSTEM TO MONITOR THE SOLUTE CONTROL AND MEDICAL EFFECTS OF RECOMBINANT HUMAN ERYTHROPOIETIN (RHUEPO) USE IN THE GENERAL DIALYSIS POPULATION. THE SPECIFIC GOALS ARE TO VERIFY THE MECHANISMS OF ALTERED DIALYZER TRANSPORT AS HEMATOCRIT (HCT) INCREASES; TO VERIFY SOLUTE KINETIC MODELS FOR UREA, POTASSIUM, AND PHOSPHOROUS; TO DEVELOP PATIENT-SPECIFIC HEMOCONCENTRATION PARAMETER AND ULTRAFILTRATION GUIDELINES TO AVOID HYPERVISCOSITY EVENTS; TO EVALUATE RHUEPO DOSING, HCT MONITORING, AND IRON STATUS MODELS; AND TO DESIGN A DATABASE AND DATA ENTRY SYSTEM TO TRACK THE CLINICAL EFFECTS OF HYPERVISCOSITY AND ITS CAUSES. TRIALS OF RHUEPO HAVE BEEN SUCCESSFUL IN MEDICALLY SELECTED PATIENTS; THIS PROJECT WILL ASSURE THAT THE TRANSITION TO THE NONSELECTED ESRD POPULATION IS EFFECTIVE AND SAFE. IN VIVO TRANSPORT STUDIES, MULTIPARAMETER IN VIVO ULTRAFILTRATION-HEMOCONCENTRATION STUDIES, AND METABOLIC BALANCE STUDIES WILL BE USED TO VERIFY TRANSPORT MECHANISMS, DEVELOP THE HEMOCONCENTRATION PARAMETER, AND VERIFY SOLUTE MODELS. BASELINE PATIENT DATA WILL BE USED TO EVALUATE PRACTICAL CLINICAL TRACKING METHODS OF RHUEPO COMPLICATIONS AND CAUSES. PHASE I WORK WILL VERIFY TRANSPORT MECHANISMS AND MODELS, AND WILL YIELD A PRELIMINARY DATABASE AND ENTRY SYSTEM. THIS INFORMATION WILL BE USED TO DEVELOP COMPREHENSIVE MODELING-DATABASE SOFTWARE DURING PHASE II.