Zerenex（ferric citrate）枸橼酸铁丸剂 - 新药热点

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Zerenex（ferric citrate）枸橼酸铁丸剂(三)

2013-07-07 01:45:47 来源: 作者: 【大中小】浏览:4958次评论:0条

001

1 Last observation carried forward was used for missing data.
In addition, as agreed to with the European Medicines Agency (EMA), the treatment difference between Zerenex and Renvela® (sevelamer carbonate) at Week 12 of the Safety Assessment Period in terms of change from baseline (Day 0) in serum phosphorus was analyzed. Zerenex successfully achieved the non-inferiority endpoint versus Renvela®.

Key Secondary Efficacy Endpoints Related to Iron

The objectives of the key iron-related secondary endpoints, which were all pre-specified in the statistical analysis plan, were to corroborate prior data which suggested that Zerenex may increase iron storage parameters and reduce the need for IV iron and/or ESAs. Zerenex met all the key secondary efficacy endpoints related to iron with statistically significant treatment differences versus the active control group (Renvela® [sevelamer carbonate] and/or Phoslo® [calcium acetate]), as follows:

Mean Change in Ferritin

Zerenex demonstrated a statistically significant treatment difference versus the active control group in mean change in serum ferritin from baseline (Day 0) to Week 52.

Mean Ferritin (ng/mL)¹	Active Controls(n=134)	Zerenex(n=249)
Baseline (Day 0)	616	595
Week 12	657	751
Week 24	658	847
Week 36	636	863
Week 48	627	882
Week 52	625	897
Change from Baseline at Week 52% Change from Baseline	91.5%	30250.8%
LS Mean Difference from Active Control Group at Week 52²		286
p-value²		p<0.0001

1 Last observation carried forward was used for missing data.
2 The LS Mean treatment difference and p-value is created via an ANCOVA model with treatment as the fixed effect and baseline as the covariate.

Mean Change in TSAT

Zerenex demonstrated a statistically significant treatment difference versus the active control group in mean change in TSAT from baseline (Day 0) to Week 52.

Mean TSAT (%)¹	Active Controls(n=131)	Zerenex(n=244)
Baseline (Day 0)	31	31
Week 12	31	40
Week 24	32	40
Week 36	30	40
Week 48	29	41
Week 52	30	39
Change from Baseline at Week 52% Change from Baseline	-1-3.2%