NCT02216656

Phase 2 Study of KHK7580

A Randomized, Double-blind, Parallel-group, Dose-finding Study of KHK7580 for Secondary Hyperparathyroidism Patients Receiving Hemodialysis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism patients receiving hemodialysis.

Conditions

• Secondary Hyperparathyroidism

Interventions

Type	Name	Description
DRUG	Placebo	Oral administration
DRUG	KHK7580 low dose	Oral administration
DRUG	KHK7580 middle dose	Oral administration
DRUG	KHK7580 high dose	Oral administration
DRUG	KRN1493	Oral administration

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-08-15
• Last updated: 2018-07-10

Locations

1 site across 1 country: Japan