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December 1, 2015

Kyowa Hakko Kirin Announces Commencement of Phase 3 Clinical Study of KHK7580 in Patients with Secondary Hyperparathyroidism in Japan

Tokyo, Japan, December 30, 2015 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") today announced the initiation of a phase 3 clinical study evaluating KHK7580 for secondary hyperparathyroidism patients receiving hemodialysis in Japan.

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

KHK7580 is a small molecular compound produced by Mitsubishi Tanabe Pharma Corporation (President & Representative Director, CEO: Masayuki Mitsuka, "Mitsubishi Tanabe Pharma"). Kyowa Hakko Kirin signed a license agreement of KHK7580 with Mitsubishi Tanabe Pharma for the rights to cooperative research, develop, market and manufacture the product in Japan and some part of Asia on March 2008.

The Kyowa Hakko Kirin Group is contributing to the health and prosperity of the world's people by pursuing advances in life sciences and technology and creating new value.


Outline of this study

ClinicalTrials.gov Identifier New window opensNCT02549391
Target Population Secondary hyperparathyroidism patients receiving hemodialysis
Trial Design Randomized, double-blind, intra-subject dose-adjustment, parallel-group, multi-center study design with an active control
Administration Group KHK7580, cinacalcet hydrochloride
Target Number of Subjects 600
Primary Objective Efficacy
Trial Location Japan
Estimated Study Completion Date March 2017



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