Velcalcetide (AMG 416), a novel peptide agonist of the calcium-sensing receptor, reduces serum parathyroid hormone and FGF23 levels in healthy male subjects

What Was Tested

The paper reports a study of Parathyroid Hormone (PTH 1-84), published as a randomized controlled trial.

Velcalcetide, also known as AMG 416, is a novel, long-acting selective peptide agonist of the calcium sensing receptor.

It is being developed as an intravenous treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney disease-mineral and bone disorder.

Who Took Part

By PubMed's age tags, the people studied were teenagers, young adults, adults and middle-aged adults, men only.

Each cohort included eight subjects randomized 6:2 to velcalcetide or placebo.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

Because people in this Parathyroid Hormone (PTH 1-84) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the participants and researchers unaware of who received Parathyroid Hormone (PTH 1-84).

The comparison arm used a placebo, so changes seen with Parathyroid Hormone (PTH 1-84) could be set against what happens without it.

What Was Measured

It is being developed as an intravenous treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney disease-mineral and bone disorder.

PubMed files the paper under topics including Biomarkers, Chronic Kidney Disease-Mineral and Bone Disorder, Fibroblast Growth Factor-23, Fibroblast Growth Factors, Hyperparathyroidism, Secondary, Parathyroid Hormone and Peptides.

Author keywords: AMG 416, FGF23, calcimimetic and velcalcetide.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Parathyroid Hormone (PTH 1-84).

The abstract goes on to report its results in about 7 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2014 (Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association), a journal based in England.

More context: the Parathyroid Hormone (PTH 1-84) compound page, all human trials.