Phase 3 Study of KHK7580

Secondary Hyperparathyroidism Clinical Trial

Official title:

Phase 3 Study of KHK7580 (A Long-term Study of KHK7580 in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549404
• Other study ID #: 7580-011
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2015
• Last updated: July 2, 2017
• Start date: September 28, 2015
• Est. completion date: December 28, 2016

Study information

• Verified date: July 2017
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This long-term study is designed to evaluate safety and efficacy of KHK7580 orally administered once daily for 52 weeks for patients with secondary hyperparathyroidism receiving hemodialysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: December 28, 2016
• Est. primary completion date: December 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

• Intact PTH level of > 240 pg/ml at screening (except subjects receiving cinacalcet hydrochloride at screening)

Exclusion Criteria:

• Change in dose or dosing regimen of cinacalcet hydrochloride or 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.

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

Drug:
• KHK7580
Oral administration

Locations

Country	Name	City	State
Japan	For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events	Adverse Event collection and assessment	Up to 52 weeks
Secondary	Percentage of subjects achieving intact parathyroid hormone (PTH) level of = 60 pg/mL and = 240 pg/mL		Up to 52 weeks
Secondary	Percentage of subjects achieving a mean percent decrease in intact PTH level of = 30% (percent change = -30%) from baseline		Up to 52 weeks
Secondary	Mean percent change in intact PTH level from baseline		Up to 52 weeks