About Etelcalcetide (formerly AMG 416) Etelcalcetide is a novel calcimimetic agent in clinical development for the treatment of SHPT
in CKD patients on hemodialysis that is administered intravenously at the end of the dialysis session.
5] Nonstandard abbreviations: FGF-23, fibroblast growth factor-23; CKD, chronic kidney disease; PTH, parathyroid hormone; sKlotho, soluble Klotho; eGFR, estimated glomerular filtration rate; AKI, acute kidney injury; NGAL, neutrophil gelatinase-associated lipocalin; SHPT
, secondary hyperparathyroidism; iFGF-23, intact FGF-23; cFGF-23, C-terminal FGF-23; ADAM-17, A desintegrin and metalloproteinases-17; CR, creatinine.
arises as a result of vitamin D insufficiency or impaired kidney function.
An estimated 70-90% of CKD patients have vitamin D insufficiency, which can lead to SHPT
and resultant debilitating bone diseases.
The findings from the study warrant further evaluation to tease out the cause of the trend, particularly because untreated SHPT
has been linked to increased mortality risk in dialysis patients, she stressed.
all proven bulls were selected based on phenotypic values from 1983 to 1987 in the CHPPT and MHPPT schemes, as well as from 1983 to 1985 in the SHPT
scheme), genetic gains after 1988 were used for comparison.
cinacalcet) is the first oral calcimimetic agent approved by the European Medicines Agency for the treatment of SHPT
in patients with CKD on dialysis.
In patients with RF and no apparent SHPT
, BSP concentrations were on average 23.
In the two Phase 3 placebo-controlled studies, an aggregate of 1,023 patients with moderate-to-severe SHPT
(PTH greater than 400 pg/mL) on hemodialysis were randomized to receive intravenous AMG 416 or placebo three times a week.
The clinical results demonstrated that KAI-4169 was highly effective in the treatment of SHPT
with 33% and 49% reductions in parathyroid hormone (PTH) from baseline in the 5 mg and 10 mg dose groups, respectively (p <0.
Study Design This was a randomized, active-controlled, double-blind, double-dummy study (study number 20120360) over 26 weeks that compared the efficacy and safety of AMG 416 with cinacalcet for the treatment of SHPT
in 683 patients with CKD receiving hemodialysis.
ADVANCE (A randomiseD VAscular calcificatioN study to evaluate the effects of CinacalcEt) is a randomised, controlled open label study to evaluate the effects of treatment with Mimpara(R) (cinacalcet) plus low-dose vitamin D, compared to flexible doses of vitamin D alone, on the progression of vascular and valvular calcification in dialysis patients with SHPT