Phase 3 Study of KHK7580

Secondary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549391
• Other study ID #: 7580-010
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 9, 2015
• Last updated: March 23, 2017
• Start date: September 2015
• Est. completion date: November 2016

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: November 2016
• Est. primary completion date: November 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

• 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• KHK7580
Oral administration
• KRN1493
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	Percentage of subjects in the evaluation period achieving a mean intact parathyroid hormone (PTH) level of = 60 pg/mL and = 240 pg/mL		Weeks 28-30
Secondary	Percentage of subjects in the evaluation period achieving a mean percent decrease in intact PTH level of = 30% (percent change = -30%) from baseline		Weeks 28-30
Secondary	Mean percent change in the evaluation period in intact PTH level from baseline		Weeks 28-30