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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02570854 | A Two-part Single- and Repeat-dose Study of CSJ137 in Anemic Chronic Hemodialysis Patients | PHASE1 | COMPLETED | 40 | — | — | Sep 22, 2015 | May 13, 2020 | Oct 12, 2021 | 13 | United States, Czechia +2 |
safety and tolerability following administration of CSJ137
to determine the minimum dose of CSJ137 that is active for treatment
| Arm | Type | Description |
|---|---|---|
| CSJ137 | EXPERIMENTAL | In Part 1 up to 48 subjects will receive a single dose of CSJ137. In Part 2, up to 40 patients will be randomized to one of 2 arms with equal allocation: one CSJ137 dose arm from Part 1 and a placebo arm. Each patient in Part 2 will receive up to 2 doses (repeat dose). |
| Placebo | PLACEBO_COMPARATOR | In Part 2, up to 40 patients will be randomized to one of 2 arms with equal allocation: one CSJ137 dose arm from Part 1 and a placebo arm. Each patient in Part 2 will receive up to 2 doses (repeat dose). |
| Name | Type | Description |
|---|---|---|
| CSJ137 | BIOLOGICAL | Starting dose is 0.010 mg/kg and dose escalation will proceed with semi-log increase steps to a maximum dose level 10 mg/kg. Subjects receive the treatment via up to 30 minutes intravenous infusion. |
| Placebo | DRUG | Subjects will be dosed with a matching placebo (vehicle control) via up to 30 minutes intravenous infusion. |
Inclusion Criteria: 1. Hemodialysis-dependent for at least 2 months prior to screening. 2. Receiving hemodialysis at least 2 times per week 3. Receiving erythropoietin (EPO) therapy. 4. Hemoglobin (Hgb) ≥ 8.5 and \< 11.5 g/dL at screening. 5. Ferritin \>500 ng/mL and ≤ 2000 ng/mL at screening. 6. T...