Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials

What Was Tested

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

To evaluate the effect of the intravenous calcimimetic etelcalcetide on serum parathyroid hormone (PTH) concentrations in patients receiving hemodialysis.

Why It Was Studied

Secondary hyperparathyroidism contributes to extraskeletal complications in chronic kidney disease.

Who Took Part

According to the abstract, 1023 patients were involved.

The age groups tagged for this paper are middle-aged adults, both men and women.

Two parallel, phase 3, randomized, placebo-controlled treatment trials were conducted in 1023 patients receiving hemodialysis with moderate to severe secondary hyperparathyroidism.

Trial A was conducted in 508 patients at 111 sites in the United States, Canada, Europe, Israel, Russia, and Australia from March 12, 2013, to June 12, 2014; trial B was conducted in 515 patients at 97 sites in the same countries from March 12, 2013, to May 12, 2014.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and parallel-group study.

The patients were allocated by chance, so the Parathyroid Hormone (PTH 1-84) group and the comparison group should start out alike.

Blinding on both sides kept the patients 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.

Groups ran in parallel: each of the patients stayed in one arm throughout.

The timeline in the abstract includes 26 weeks.

Intravenous administration of etelcalcetide (n = 503) or placebo (n = 513) after each hemodialysis session for 26 weeks.

What Was Measured

Secondary hyperparathyroidism contributes to extraskeletal complications in chronic kidney disease.

PubMed files the paper under topics including Calcimimetic Agents, Calcium, Fibroblast Growth Factor-23, Fibroblast Growth Factors, Hyperparathyroidism, Secondary, Parathyroid Hormone and Peptides.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Parathyroid Hormone (PTH 1-84) in 1023 patients in people with hyperparathyroidism over 26 weeks.

With several hundred people or more, it is a fairly large study for this kind of research.

Results are reported in around 9 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2017 (JAMA), a journal based in United States.

More context: the Parathyroid Hormone (PTH 1-84) compound page, Hyperparathyroidism research.