Phase 3 Study of KHK7580

Summary

The purpose of this study is to evaluate the efficacy and safety of KHK7580 orally administered once daily for 30 weeks in subjects with secondary hyperparathyroidism (SHPT) receiving hemodialysis in a randomized, double-blind, intra-subject dose-adjustment, parallel-group design with cinacalcet hydrochloride as an active control.

Timeline

Start

2015-09

Primary completion

2016-11

Completion

2016-11

Publications

• Tokumoto M, Tokunaga S, Asada S, Endo Y, Kurita N, Fukagawa M, Akizawa T. Predictive factors requiring high-dose evocalcet in hemodialysis patients with secondary hyperparathyroidism. PLoS One. 2022 Dec 13;17(12):e0279078. doi: 10.1371/journal.pone.0279078. eCollection 2022.
• Shigematsu T, Asada S, Endo Y, Kawata T, Fukagawa M, Akizawa T. Evocalcet with vitamin D receptor activator treatment for secondary hyperparathyroidism. PLoS One. 2022 Feb 17;17(2):e0262829. doi: 10.1371/journal.pone.0262829. eCollection 2022.

Drugs

Indications