Chronic Kidney Disease Clinical Trial
Official title:
Safety and Efficacy of Sustained Erythropoietin Therapy of Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD) Dialysis Patients Using MDGN201 TARGTEPO
The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment.
This is a Phase I-II, open-label study. Each patient will receive targeted dose of EPO delivered via TARGTEPO. The targeted doses will be determined according to 3 cohorts as follows: Group A (18-25 IU/Kg/day), Group B (35-45 IU/Kg/day), Group C (55-65 IU/Kg/day). The objective is to evaluate safety and biologic activity of TARGTEPO treatment when maintaining Hb levels within the target range of 9-12 g/dl. Biological activity assessments will include duration of TARGTEPO secretion as measured by serum EPO levels above baseline ;
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