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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01991483 | A Study of LY2928057 in Hemodialysis Participants | PHASE1 | COMPLETED | 28 | — | — | Dec 1, 2013 | Oct 1, 2015 | Mar 7, 2019 | 4 | United States |
A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.
| Arm | Type | Description |
|---|---|---|
| LY2928057 (No ESA) | EXPERIMENTAL | Multiple doses of LY2928057 administered intravenously (IV) either once every 2 weeks (Q2W) or once per week (QW) for 6 weeks. Participants discontinued their personal physician-prescribed erythropoiesis stimulating agent (ESA) before treatment. |
| LY2928057 (Reduced ESA) | EXPERIMENTAL | Multiple doses of LY2928057 administered IV either Q2W or QW for 6 weeks. Participants reduced their personal physician-prescribed ESA dose before treatment. |
| Placebo (No ESA) | PLACEBO_COMPARATOR | Multiple doses of placebo administered IV either Q2W or QW for 6 weeks. Participants discontinued their personal physician-prescribed ESA dose before treatment. |
| Placebo (Reduced ESA) | PLACEBO_COMPARATOR | Multiple doses of placebo administered IV either Q2W or QW for 6 weeks. Participants reduced their personal physician-prescribed ESA dose before treatment. |
| Name | Type | Description |
|---|---|---|
| LY2928057 | DRUG | Administered intravenously |
| Placebo | DRUG | Administered intravenously |
Inclusion Criteria: * Participants having end-stage renal disease (ESRD), have received an erythropoiesis stimulating agent (ESA) at least weekly for 2 weeks prior to screening, and have been receiving adequate maintenance hemodialysis (3 times weekly) for at least 12 weeks prior to screening (that...