The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment in Peritoneal Dialysis patients
This is a Phase II, open-label study. Each patient will receive targeted dose of Erythropoietin (EPO) delivered via TARGTEPO. The targeted doses will be determined according to 2 cohorts as follows: Group A (18-25 IU/Kg/day), Group B (35-45 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
MDGN201 TARGTEPO secreting EPO
Barzili Medical Center
Ashkelon, Israel
Assaf Harofeh Medical Center
Zrifin, Israel
Patients Who Achieved Biological Activity of MDGN201 TARGTEPO Secretion as Measured by Serum Erythropoietin (EPO) Levels Above Baseline
Time frame: 52 weeks
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