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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01693029 | Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa | PHASE3 | COMPLETED | 435 | — | — | Sep 1, 2012 | Mar 1, 2015 | Jul 2, 2017 | 52 | United States |
Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .
Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .
| Arm | Type | Description |
|---|---|---|
| HX575 epoetin alfa | EXPERIMENTAL | HX575, recombinant human epoetin alfa |
| US-licensed epoetin alfa | ACTIVE_COMPARATOR | US-licensed recombinant human epoetin alfa |
| Name | Type | Description |
|---|---|---|
| HX575 epoetin alfa | DRUG | Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL. |
| US-licensed epoetin alfa | DRUG | Solution for subcutaneous injection. |
Inclusion Criteria: * Patients with end stage renal disease (stage CKD 5d), receiving stable subcutaneous maintenance therapy with Epogen® or Procrit® at least once per week * Mean hemoglobin level between 9.0 - 11.5 g/dL during the screening period * Adequate iron substitution Exclusion Criteria:...