Phase 3 Study of KHK7580

NCT ID: NCT02549417

Last Updated: 2017-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-29
• Study Completion Date: 2016-12-22

Brief 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.

Conditions

Secondary Hyperparathyroidism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KHK7580

Group Type: EXPERIMENTAL

KHK7580

Intervention Type: DRUG

Oral administration

Interventions

KHK7580

Oral administration

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Tokyo, , Japan

Countries

Japan

References

Tsuruya K, Shimazaki R, Fukagawa M, Akizawa T; Evocalcet Study Group. Efficacy and safety of evocalcet in Japanese peritoneal dialysis patients. Clin Exp Nephrol. 2019 Jun;23(6):739-748. doi: 10.1007/s10157-019-01692-y. Epub 2019 Apr 6.

Reference Type: DERIVED

PMID: 30955188 (View on PubMed)

Other Identifiers

7580-012

Identifier Type: -

Identifier Source: org_study_id