Phase 3 Study of KHK7580

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02549404

Enrollment

137

Registered

2015-09-15

Start date

2015-09-28

Completion date

2016-12-28

Last updated

2017-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Hyperparathyroidism

Brief 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.

Interventions

DRUGKHK7580

Oral administration

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with adverse events	Up to 52 weeks	Adverse Event collection and assessment

Secondary

Measure	Time frame
Percentage of subjects achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline	Up to 52 weeks
Mean percent change in intact PTH level from baseline	Up to 52 weeks
Percentage of subjects achieving intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL	Up to 52 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026