MedTrace Logo

Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia

NCT03822507 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2022-04-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and the safety of KHK7580 orally administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active control in subjects with secondary hyperparathyroidism receiving hemodialysis in China, Korea, Hong Kong and Taiwan.

Conditions

  • Secondary Hyperparathyroidism

Interventions

DRUG

KHK7580

oral administration

DRUG

Cinacalcet Hydrochloride

oral administration

Sponsors & Collaborators

  • Kyowa Kirin China Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Kyowa Kirin Korea Co., Ltd.

    collaborator INDUSTRY

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-09
Primary Completion
2021-09-23
Completion
2021-09-23

Countries

  • China
  • Hong Kong
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03822507 on ClinicalTrials.gov