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Abstract: ASN Annual Meeting -- San Diego |
Martin KJ, Bushinsky DA, Cheng S, et al.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Fixed Dose Study of AMG 223 in Subjects with CKD on Hemodialysis with Hyperphosphatemia.
ASN Annual Meeting -- San Diego
J Am Soc Nephrol (Nov) 20:367A 2009
Despite the association with morbidity and mortality, control of hyperphosphatemia remains difficult. AMG 223 is a novel polymer-based, nonmetallic, phosphate binder in development for the treatment of hyperphosphatemia. The main objectives of this study were to demonstrate (1) significant serum P reduction compared with placebo (PL), (2) a dose response for AMG 223, and (3) the safety profile over a 3 week treatment period. Subjects with serum phosphorus (P) of 3.5-6.5 mg/dL entered a washout, followed by 3:1 (AMG 223:PL) randomization to 1 of 8 fixed-dose groups (4 PL, 4 AMG 223) if serum P increased by
1.5 mg/dL and was >5.5 mg/dL.
AMG 223 Placebo (N=39) 1g TID (n=31) 3g TID (n=32) 4g TID (n=31) 5g TID (n=31) LS Mean (SEM) Change from Baseline 0.07 (0.24) -0.63 (0.26) -1.50 (0.26) -1.81 (0.27) -2.16 (0.26) n (proportion %) with serum P reduction
11/38 (29%) 12/30 (40%) 22/32 (69%) 23/29 (79%) 22/30 (73%) P<0.0001 compared to placebo
AMG 223 significantly reduced serum P and a consistent dose response was seen across all 4 AMG 223 dose groups based on the proportion of subjects with serum P reduction of
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