Phase 3 Study of KHK7580

NCT ID: NCT02549391

Last Updated: 2017-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 634 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-11-30

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of KHK7580 orally administered once daily for 30 weeks in subjects with secondary hyperparathyroidism (SHPT) receiving hemodialysis in a randomized, double-blind, intra-subject dose-adjustment, parallel-group design with cinacalcet hydrochloride as an active control.

Conditions

Secondary Hyperparathyroidism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

KHK7580

Group Type: EXPERIMENTAL

KHK7580

Intervention Type: DRUG

Oral administration

KRN1493

Group Type: ACTIVE_COMPARATOR

KRN1493

Intervention Type: DRUG

Oral administration

Interventions

KHK7580

Oral administration

Intervention Type: DRUG

KRN1493

Oral administration

Intervention Type: DRUG

Other Intervention Names

cinacalcet hydrochloride

Eligibility Criteria

Inclusion Criteria

• Personally submitted written voluntary informed consent to participate in the study
• Stable chronic renal disease treated with hemodialysis 3 times weekly for at least 12 weeks before screening
• Mean intact PTH level of > 240 pg/ml at screening, at 2 weeks and 1 week before the start of study treatment

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

Tokumoto M, Tokunaga S, Asada S, Endo Y, Kurita N, Fukagawa M, Akizawa T. Predictive factors requiring high-dose evocalcet in hemodialysis patients with secondary hyperparathyroidism. PLoS One. 2022 Dec 13;17(12):e0279078. doi: 10.1371/journal.pone.0279078. eCollection 2022.

Reference Type: DERIVED

PMID: 36512619 (View on PubMed)

Shigematsu T, Asada S, Endo Y, Kawata T, Fukagawa M, Akizawa T. Evocalcet with vitamin D receptor activator treatment for secondary hyperparathyroidism. PLoS One. 2022 Feb 17;17(2):e0262829. doi: 10.1371/journal.pone.0262829. eCollection 2022.

Reference Type: DERIVED

PMID: 35176038 (View on PubMed)

Other Identifiers

7580-010

Identifier Type: -

Identifier Source: org_study_id