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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00112008 | Study for Subjects With Chronic Kidney Disease(CKD) Not Receiving Dialysis | PHASE3 | COMPLETED | 100 | — | — | May 1, 2004 | Mar 1, 2005 | Jul 10, 2009 | - | — |
| Arm | Type | Description |
|---|---|---|
| darbepoetin alfa | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| De Novo Administration of Darbepoetin Alfa | DRUG | Administration Q2W for 18 weeks. starting dose is 0.75 mcg/kg rounded to the nearest dose: 20, 30, 40, 50, 60, 80, 100, 150, 200 0r 300 mcg. Titrate to maintain Hb within 11.0 - 13.0 g/dL |
Inclusion Criteria: - Diagnosis of CKD and not expected to initiate dialysis for the duration of the study - Estimated glomerular filtration rate (eGFR): greater than or equal to 15 mL/min and less than or equal to 60 mL/min measured by the following modified MDRD (Modification of Diet in Renal Dise...