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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03581591 | Open Label Trial Assessing Safety and Efficacy of Burosumab (KRN23), in a Patient With ENS and Hypophosphatemic Rickets | PHASE3 | COMPLETED | 1 | — | — | Jan 31, 2018 | Dec 6, 2019 | Jan 18, 2020 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Primary; open label | EXPERIMENTAL | Injection of Burosumab every two to three weeks based on Serum Phosphorus level of subject. Initial dose to be 0.3 mg/kg. Subsequent dosing will be titrated up or down depending on Serum Phosphorus level for that time period. |
| Name | Type | Description |
|---|---|---|
| Burosumab | BIOLOGICAL | recombinant human IgG1 monoclonal antibody to fibroblast growth factor 23) |
Inclusion Criteria: 1. Patient has confirmed ENS by physician diagnosis 2. Patient has confirmed FGF23 elevations in the context of low serum phosphorous \< 4.1 mg/dL 3. Patient able to tolerate KRN23 treatment 4. Have a corrected serum calcium level \< 10.8mg/dL 5. Have an eGFR \>60 ml/min 6. Must...