Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=28057872
&cmd=llinks): Failed to open stream: HTTP request failed! HTTP/1.1 429 Too Many Requests
in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 215
A phase 3, multicentre, randomized, double-blind, placebo-controlled,
parallel-group study to evaluate the efficacy and safety of etelcalcetide
(ONO-5163/AMG 416), a novel intravenous calcimimetic, for secondary
hyperparathyroidism in Japanese haemodialysis patients
#MMPMID28057872
Fukagawa M
; Yokoyama K
; Shigematsu T
; Akiba T
; Fujii A
; Kuramoto T
; Odani M
; Akizawa T
Nephrol Dial Transplant
2017[Oct]; 32
(10
): 1723-1730
PMID28057872
show ga
BACKGROUND: Secondary hyperparathyroidism (SHPT) is a major complication
associated with chronic kidney disease. We evaluated the efficacy and safety of
etelcalcetide (ONO-5163/AMG 416), a novel intravenous calcimimetic, in Japanese
haemodialysis patients with SHPT. METHODS: In this phase 3, multicentre,
randomized, double-blind, placebo-controlled, parallel-group study, etelcalcetide
was administered three times per week at an initial dose of 5?mg, and
subsequently adjusted to doses between 2.5 and 15?mg at 4-week intervals for 12
weeks. A total of 155 SHPT patients with serum intact parathyroid hormone (iPTH)
levels??300?pg/mL were assigned to receive etelcalcetide (n?=?78) or placebo
(n?=?77). The primary endpoint was the proportion of patients with decreased
serum iPTH to the target range proposed by the Japanese Society for Dialysis
Therapy (60-240?pg/mL). The major secondary endpoint was the proportion of
patients with??30% reductions in serum iPTH from baseline. RESULTS: The
proportion of patients meeting the primary endpoint was significantly higher for
etelcalcetide (59.0%) versus placebo (1.3%). Similarly, the proportion of
patients meeting the major secondary endpoint was significantly higher for
etelcalcetide (76.9%) versus placebo (5.2%). Serum albumin-corrected calcium,
phosphorus and intact fibroblast growth factor-23 levels were decreased in the
etelcalcetide group. Nausea, vomiting and symptomatic hypocalcaemia were mild
with etelcalcetide. Serious adverse events related to etelcalcetide were not
observed. CONCLUSIONS: This study demonstrated the efficacy and safety of
etelcalcetide. As the only available intravenous calcium-sensing receptor
agonist, etelcalcetide is likely to provide a new treatment option for SHPT in
haemodialysis patients.
free
free
free
