Pharmacodynamics of evocalcet for secondary hyperparathyroidism in Japanese hemodialysis patients

Clinical and Experimental Nephrology
Takashi ShigematsuEvocalcet Study Group

Abstract

This study investigated the pharmacokinetics, pharmacodynamics, and safety of multiple doses of evocalcet in Japanese secondary hyperparathyroidism (SHPT) patients receiving hemodialysis. 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. Plasma evocalcet levels reached steady state 3 days after the first day of administration. Pharmacodynamic analyses showed that evocalcet effectively reduced intact PTH and serum-corrected calcium levels. Adverse events (AEs) occurred in 29.6 and 62.5% of patients receiving multiple doses of 1 or 4 mg, respectively. The AE 'blood calcium decreased' occurred in eight patients (33.0%) after multiple doses of 4 mg. All events were mild, except for one patient with a moderate AE (abnormal liver function) and one patient with a ...Continue Reading

References

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Sep 27, 2018·Clinical Pharmacology : Advances and Applications·Takashi ShigematsuTadao Akizawa

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Citations

Sep 6, 2019·Therapeutic Apheresis and Dialysis : Official Peer-reviewed Journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy·Tadao AkizawaMasafumi Fukagawa
Jun 20, 2020·Expert Review of Endocrinology & Metabolism·Naoto HamanoMasafumi Fukagawa
Sep 12, 2020·F1000Research·María E Rodríguez-Ortiz, Mariano Rodríguez
Apr 8, 2019·Clinical and Experimental Nephrology·Kazuhiko TsuruyaUNKNOWN Evocalcet Study Group
Jun 5, 2020·International Journal of Nephrology and Renovascular Disease·Takashi ShigematsuTadao Akizawa

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