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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00527137 | NESP Pediatric Study | PHASE3 | COMPLETED | 120 | — | — | Aug 1, 2000 | Nov 1, 2004 | May 8, 2013 | - | — |
| Arm | Type | Description |
|---|---|---|
| rHuEPO | ACTIVE_COMPARATOR | - |
| darbepoetin alfa | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| darbepoetin alfa | DRUG | Dose 100U rHuEPO = 0.42 mcg NESP; adjust as necessary (+/- 25% of the starting dose) to maintain Hb withing 10.0 - 12.5 g/dL |
| rHuEPO | DRUG | same as previous rHuEPO dose at randomization; adjust as necessary (+/- 25% of the starting dose) to maintain Hb withing 10.0 - 12.5 g/dL |
Inclusion Criteria: * 1 to 18 years of age * ESRD receiving dialysis or CRI with eGFR less than 30 mL/min * Baseline hemoglobin 9.5 - 12.5 g/dL and iron replete * Stable rHuEPO therapy for 8 weeks Exclusion Criteria: * Scheduled for a living-related kidney transplant * Uncontrolled blood pressure...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Fresenius Medical Care AG Sponsored ADR | FMS | 1 | NA | Undisclosed |
| Merit Medical Systems, Inc. | MMSI | 1 | — | Undisclosed |
| MiniMed Group, Inc. | MMED | 1 | — | Undisclosed |