Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia

A Phase 3, 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 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03822507

Enrollment

404

Registered

2019-01-30

Start date

2019-04-09

Completion date

2021-09-23

Last updated

2022-04-25

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 the safety of KHK7580 orally administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active control in subjects with secondary hyperparathyroidism receiving hemodialysis in China, Korea, Hong Kong and Taiwan.

Interventions

DRUGKHK7580

oral administration

DRUGCinacalcet Hydrochloride

oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Personally submitted written voluntary informed consent to participate in the study 2. Aged ≧18 years at the time of consent 3. Stable chronic renal failure treated with hemodialysis 3 times weekly for at least 12 weeks before screening 4. Intact PTH level (centrally measured) of \>300 pg/mL at screening 5. Corrected serum Ca level (centrally measured) of ≧9.0 mg/dL at screening

Exclusion criteria

1. Treatment with cinacalcet hydrochloride within 2 weeks before screening 2. Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or Ca preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening 3. Change in prescribed conditions of dialysis (dialysate Ca concentration, prescribed dialysis time, and prescribed number of dialysis per week) within 2 weeks before screening 4. Treatment with bisphosphonates, denosumab or teriparatide within 24 weeks before screening 5. Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening 6. Severe heart disease (e.g., ≧ Class Ⅲ per New York Heart Association classification) 7. Severe hepatic dysfunction (e.g., treatment with antiviral therapy) 8. Uncontrolled hypertension and/or diabetes

Design outcomes

Primary

Measure	Time frame
Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period	Week 50- Week 52

Secondary

Measure	Time frame
Percentage of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period	Week 50- Week 52
Number of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period	Week 50- Week 52
Percentage of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period	Week 50- Week 52
Number of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period	Week 50- Week 52
corrected serum Ca level	Week 50- Week 52
serum P level	Week 50- Week 52
Intact PTH level	Week 50- Week 52

Countries

China, Hong Kong, South Korea, Taiwan

Outcome results

None listed

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