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 a patient specific hemoconcentration parameter and ultrafiltration guidelines to avoid hyperviscosity events; and to design a data base and data entry system to start the tracking of clinical effects of hyperviscosity and its causes for patients in individual and multiple centers. Trials of rHuEpo have been successful in medically selected patients; this project will assure that the transition to the non-selected ESRD population is effective and safe. In vivo transport studies, multi-parameter 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; it will yield a preliminary data base and entry system. This information will be a base for development of comprehensive modeling-data base software during Phase II. The quality of dialysis is attracting increased attention with more rapid/shorter treatment, even without fundamental patient changes. Dialysis centers cannot develop individual clinical monitoring systems to track rHuEpo use in a small, medically diverse group of patients. A central data base system that permits clinics to individualize treatment of high HCT patients and assure safe delivery of therapy is expected to be of commercial importance.
