Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MDGN201 TARGTEPO · 1 trial · 2 indications
Due to the small sample size and the dispersion of total EPO secretion, the efficacy analyses were performed on all of the patients as a single cohort of intended dose between 25 and 45 U/Kg/d.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | MDGN201 TARGTEPO secreting EPO (18-25 IU/Kg/day) |
| Group B | EXPERIMENTAL | MDGN201 TARGTEPO secreting EPO (35-45 IU/Kg/day) |
| Group C | EXPERIMENTAL | MDGN201 TARGTEPO secreting EPO (55-65 IU/Kg/day) |
| Name | Type | Description |
|---|---|---|
| MDGN201 TARGTEPO | BIOLOGICAL | Erythropoietin secreted by TARGTEPO transduced with MDGN201 |
Inclusion Criteria: 1. For ESRD patients: Subject diagnosed with Anemia due to Chronic Renal Failure CKD stage 5 on hemodialysis treatment for at least 6 months. Average Hb during last month between 9 to 12g/dL. 2. Kt/V \>1 3. INR not higher than 1.2 4. Serum albumin \>3.5 5. Subjects with adequate...
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