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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01478971 | Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis | PHASE3 | COMPLETED | 184 | — | — | Oct 1, 2011 | Feb 1, 2013 | Sep 20, 2016 | 5 | United States |
| Arm | Type | Description |
|---|---|---|
| peginesatide injection | EXPERIMENTAL | In the first 6 months participants received standard of care treatment with epoetin (the Standard of Care Period \[SCP\]), followed by a 1-week erythropoiesis-stimulating agent (ESA)-Free Period, followed by peginesatide injection for 6 months (the Peginesatide Treatment Period \[PTP\]). |
| Name | Type | Description |
|---|---|---|
| Epoetin | DRUG | Commercially available epoetin alfa administered weekly, twice weekly, or thrice weekly at an initial starting dose, frequency of administration, and mode of administration (intravenous \[IV\] or subcutaneous \[SC\]) individually determined for each participant using the site's usual standard of care. Subsequent dose adjustments or dose holds may have been made in order to maintain a hemoglobin concentration of \<11 g/dL. |
| Peginesatide | DRUG | Administered as a once monthly intravenous (IV) or subcutaneous (SC) injection. The initial dose of peginesatide injection was based on the final weekly dose of epoetin administered in the SCP; subsequent doses may have been adjusted in order to maintain hemoglobin concentrations at \<11 g/dL. |
Inclusion Criteria: * Have provided written informed consent in accordance with institutional, local, and national guidelines * Are ≥18 years of age at the start of screening * Have been on in-center hemodialysis for ≥12 weeks at the start of screening * Are currently maintained on Epoetin at the s...