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Phase 3 Study of KHK7580 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Phase 3 Study of KHK7580

Phase 3 Study of KHK7580 (A Clinical Study of KHK7580 in Subjects With Secondary Hyperparathyroidism Receiving Peritoneal Dialysis)

NCT02549417•Kyowa Kirin Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is designed to evaluate efficacy and safety of KHK7580 orally administered once daily for 32 weeks for patients with secondary hyperparathyroidism receiving peritoneal dialysis. After 32-week treatment period, the subjects will receive KHK7580 in the 20-week extension period to evaluate long-term safety and efficacy.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Personally submitted written voluntary informed consent to participate in the study
•Stable chronic renal disease treated with peritoneal dialysis for at least 16 weeks before screening
•Intact PTH level of \> 240 pg/ml at screening

Exclusion Criteria

•Treatment with cinacalcet hydrochloride within 2 weeks before screening;
•Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening;
•Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening;
•Severe heart disease;
•Severe hepatic dysfunction;
•Uncontrolled hypertension and/or diabetes;
•Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening;
•Primary hyperparathyroidism;
•Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.

Locations (1)

For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin

Tokyo, Japan

Key Dates

Start Date

September 29, 2015

Primary Completion Date

December 22, 2016

Completion Date

December 22, 2016

Last Updated

July 5, 2017

Enrollment

ACTUAL participants

Conditions

Secondary Hyperparathyroidism

Interventions

KHK7580

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: July 5, 2017Data 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.

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Phase 3 Study of KHK7580

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