Phase 3 Study of KHK7580

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)

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02549391

Enrollment

634

Registered

2015-09-15

Start date

2015-09-30

Completion date

2016-11-30

Last updated

2017-03-24

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

Conditions

Secondary Hyperparathyroidism

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.

Interventions

DRUGKHK7580

Oral administration

DRUGKRN1493

Oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

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 * 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
Mean percent change in the evaluation period in intact PTH level from baseline	Weeks 28-30

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026