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Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia

A Phase 3, Randomized, Double-Blind, Intra-Subject Dose-Adjustment, Parallel-Group Study of KHK7580 and Cinacalcet Hydrochloride in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis

NCT03822507•Kyowa Kirin Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Personally submitted written voluntary informed consent to participate in the study
•2. Aged ≧18 years at the time of consent
•3. Stable chronic renal failure treated with hemodialysis 3 times weekly for at least 12 weeks before screening
•4. Intact PTH level (centrally measured) of \>300 pg/mL at screening
•5. Corrected serum Ca level (centrally measured) of ≧9.0 mg/dL at screening

Exclusion Criteria

•1. Treatment with cinacalcet hydrochloride within 2 weeks before screening
•2. Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or Ca preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening
•3. Change in prescribed conditions of dialysis (dialysate Ca concentration, prescribed dialysis time, and prescribed number of dialysis per week) within 2 weeks before screening
•4. Treatment with bisphosphonates, denosumab or teriparatide within 24 weeks before screening
•5. Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening
•6. Severe heart disease (e.g., ≧ Class Ⅲ per New York Heart Association classification)
•7. Severe hepatic dysfunction (e.g., treatment with antiviral therapy)
•8. Uncontrolled hypertension and/or diabetes

Locations (34)

Research site_29

Changsha, China

Research site_34

Dalian, China

Research site_25

Foshan, China

Research site_22

Guangzhou, China

Research site_23

Guangzhou, China

Research site_30

Guangzhou, China

Research site_28

Hefei, China

Research site_32

Nanjing, China

Research site_33

Nanjing, China

Research site_24

Shanghai, China

Key Dates

Start Date

April 9, 2019

Primary Completion Date

September 23, 2021

Completion Date

September 23, 2021

Last Updated

April 25, 2022

Enrollment

404

ACTUAL participants

Conditions

Secondary Hyperparathyroidism

Interventions

KHK7580

DRUG

Cinacalcet Hydrochloride

DRUG

A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

NCT03633708

Secondary HyperparathyroidismChronic Kidney Disease

View study

RECRUITINGNA

Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism

NCT04922892

Secondary Hyperparathyroidism;Parathyroidectomy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 25, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia

Inclusion Criteria

Exclusion Criteria

A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism

A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)

Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial

The Effect of Increasing Dialysate Calcium on T50 in Subjects With Secondary Hyperparathyroidism and ESKD

Diagnostic Accuracy of 3T MR for Secondary Hyperparathyroidism Comparison With 4DCT