Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02117427 | TARGTEPO Treatment for Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD) | PHASE1 | COMPLETED | 11 | — | — | May 27, 2014 | Mar 20, 2017 | Oct 30, 2018 | 5 | Israel |
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...