Pharmacodynamics of evocalcet for secondary hyperparathyroidism in Japanese hemodialysis patients.

ABSTRACT:

Background

This study investigated the pharmacokinetics, pharmacodynamics, and safety of multiple doses of evocalcet in Japanese secondary hyperparathyroidism (SHPT) patients receiving hemodialysis.

Methods

In this multicenter, open-label study, conducted between August 2013 and March 2014, 27 patients received multiple doses of 1 and 4 mg evocalcet for 14 days, followed by an extension period of multiple doses of 8 and 12 mg evocalcet for 7 days using an intra-patient dose escalation protocol. Pharmacodynamic parameters consisted of measurement of intact parathyroid hormone (PTH), serum-corrected calcium, serum phosphorus and intact fibroblast growth factor 23 concentrations. Safety was assessed by analysis of adverse events.

Results

Plasma evocalcet levels reached s

SUBMITTER: Shigematsu T 

PROVIDER: S-EPMC6510802 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature