Date: 2014-07-17
Type of information: Results
phase: 3
Announcement: results
Company: Amgen (USA - CA)
Product: AMG 416
Action
mechanism: calcimimetic agent. AMG 416 is a novel calcimimetic agent in Phase 3 clinical development for the treatment of secondary hyperparathyroidism that is administered intravenously in patients with CKD who are receiving hemodialysis. AMG 416 binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in parathyroid hormone.
Disease: secondary hyperparathyroidism in patients with chronic kidney disease
Therapeutic area: Hormonal diseases - Endocrine diseases - Renal diseases - Kidney diseases
Country:
Trial
details: The trial was a 26-week, randomized, double-blind, placebo-controlled study (study number 20120230) that evaluated the efficacy and safety of AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in 515 patients with CKD receiving hemodialysis. Patients received AMG 416 or placebo three times per week by intravenous injection with each hemodialysis treatment. Doses ranged from a minimum of 2.5 mg to a maximum of 15 mg. Patients also received standard of care which could include calcium supplements, vitamin D sterols and phosphate binders, if prescribed by the individual physician. Secondary endpoints included the proportion of patients with PTH = 300 pg/mL during the EAP and the percent change from baseline during the EAP in values for PTH, serum cCa, corrected calcium-phosphorus product (cCa x P) and P.
Latest
news: * On July 17, 2014, Amgen announced that a Phase 3 study evaluating AMG 416 (formerly known as velcalcetide) for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis, met its primary and all secondary endpoints. The primary endpoint was the proportion of patients with > 30 percent reduction from baseline in parathyroid hormone (PTH) levels during an Efficacy Assessment Phase (EAP) defined as the period between weeks 20 and 27. Amgen obtained AMG 416 as part of the acquisition of KAI Pharmaceuticals, Inc. in July 2012 and these are the first results to be reported from the Phase 3 program. In the AMG 416 group, 75.3 percent of patients achieved a > 30 percent reduction from baseline in PTH compared with 9.6 percent in the placebo arm, a statistically significant result. Secondary endpoints included the percent change from baseline during the EAP in serum phosphorus (P) concentration (mean changes of -9.63 and -1.60 percent among patients in the AMG 416 and placebo arms, respectively) and corrected calcium (cCa) concentration (mean changes of -6.69 and 0.58 percent among patients in the AMG 416 and placebo arms, respectively). Both of these secondary endpoint results were statistically significant. Treatment-emergent adverse events (TEAEs) were reported in 91.7 and 81.1 percent of patients who received AMG 416 and placebo, respectively. TEAEs that were reported in > 10 percent of patients who received AMG 416 included (AMG 416 vs placebo, respectively): blood calcium decreased (66.7 and 12.0 percent), diarrhea (14.3 and 10.0 percent), and muscle spasms (11.1 and 6.2 percent). Serious adverse events (SAEs) were reported in 24.6 and 27.4 percent of patients who received AMG 416 and placebo, respectively. TEAEs of nausea were reported in 9.1 and 7.3 percent of patients who received AMG 416 and placebo, respectively. TEAEs of vomiting were reported in 7.5 and 3.1 percent of patients treated with AMG 416 and placebo, respectively. TEAEs of hypocalcemia (symptomatic) were reported in 6.7 percent of patients who received AMG 416 versus none in the placebo group.
