THOUSAND OAKS (dpa-AFX) - Amgen (AMG) announced that a Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism or SHPT in patients with chronic kidney disease or CKD, receiving hemodialysis, met its primary and all secondary endpoints.
The company noted that the primary endpoint was the proportion of patients with 30 percent reduction from baseline in parathyroid hormone levels during an Efficacy Assessment Phase 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.
Amgen said this was a 26-week, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of AMG 416 for the treatment of 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 and P.
Giving a brief description on Secondary HPT, the company said it is a common and serious condition that is often progressive among patients with CKD and it affects many of the approximately two million people throughout the world who are receiving dialysis. The disorder develops early as an adaptive response to declining kidney function when the parathyroid glands increase the production of PTH in an effort to maintain normal levels of calcium and phosphorus.
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