Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CSJ137 · 1 trial · 1 indication
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...
CSJ137 is an investigational monoclonal antibody being developed for anemia and iron-deficiency. It was studied in anemic chronic hemodialysis patients. The drug is in Phase 1 clinical development and is not yet approved.
CSJ137 is a monoclonal antibody, but its specific molecular target has not been disclosed. It is being investigated for its potential role in treating anemia and iron-deficiency in patients with chronic kidney disease on hemodialysis.
CSJ137 is being developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical trials.
CSJ137 is in Phase 1 clinical development. It has completed one Phase 1 trial, and no active trials are currently listed. The drug is investigational and has not been approved by regulatory authorities.
CSJ137 has been studied in one completed Phase 1 trial, NCT02570854, titled 'A Two-part Single- and Repeat-dose Study of CSJ137 in Anemic Chronic Hemodialysis Patients.' The trial enrolled 40 participants across the United States, Czechia, Israel, and the United Kingdom.