Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Omontys, Hematide, AF37702 Injection, AF37702
Peginesatide · 7 trials · 4 indications
The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during study Weeks 29 through 36.
Percentage of participants who experienced increase and maintain hemoglobin levels (two consecutive values) greater than or equal to the lower limit (11 g/dL) in the absence of red blood cell transfusion in the previous 28 days by week 24 were reported.
| Arm | Type | Description |
|---|---|---|
| Peginesatide | EXPERIMENTAL | - |
| Epoetin alfa | ACTIVE_COMPARATOR | - |
| 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 \[PTP\]). |
| Peginesatide 0.025 mg/kg | EXPERIMENTAL | - |
| Peginesatide 0.04 mg/kg | EXPERIMENTAL | - |
| Darbepoetin Alfa | ACTIVE_COMPARATOR | - |
| Peginesatide 0.08 mg/kg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| peginesatide | DRUG | Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period. |
| Epoetin Alfa | DRUG | Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period. |
| 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. |
| Darbepoetin alfa | DRUG | As prescribed, starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL. |
Inclusion Criteria 1. Participants with chronic renal failure on hemodialysis for ≥ 3 months prior to randomization. 2. On intravenous epoetin alfa maintenance therapy continuously prescribed for a minimum of 8 weeks prior to randomization. 3. Four consecutive hemoglobin values with a mean ≥ 10.0 a...
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Peginesatide is an investigational small molecule developed by Takeda Pharmaceutical Company Limited for the treatment of anemia associated with chronic kidney disease and chronic renal failure. It is being studied in patients on dialysis and in patients who do not require dialysis, including those previously treated with erythropoiesis-stimulating agents.
Peginesatide targets EPOR, the erythropoietin receptor, and acts as an agonist. By binding and activating this receptor, it stimulates erythropoiesis, the production of red blood cells, which is the intended approach to correcting anemia in patients with chronic kidney disease or chronic renal failure.
Peginesatide is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor behind the clinical development program evaluating the drug in anemia associated with chronic kidney disease and chronic renal failure.
Peginesatide is in Phase 2 development. It is an investigational drug and is not approved for commercial use. Its clinical program includes four trials, of which three are completed and none are currently active, with a total enrollment of 1,293 participants across the studies.
Peginesatide has been studied in four registered trials: NCT01478971, a Phase 3 conversion study from epoetin alfa in dialysis patients; NCT00752791 in peritoneal dialysis participants; NCT00752609 in chronic renal failure participants; and NCT00680043 in dialysis participants not receiving an ESA. All four are completed.
Peginesatide is being developed for the maintenance treatment of anemia in patients with chronic kidney disease and chronic renal failure, including those on peritoneal dialysis, hemodialysis, or not requiring dialysis. The trials enrolled adults previously treated with epoetin or darbepoetin alfa, as well as patients not receiving an ESA.