Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia

  • STATUS
    Recruiting
  • End date
    Mar 25, 2022
  • participants needed
    400
  • sponsor
    Kyowa Kirin Co., Ltd.
Updated on 25 January 2021
serum calcium
chronic renal failure
cinacalcet
secondary hyperparathyroidism
parathyroid hormones
khk7580

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.

Details
Condition Hyperparathyroidism, Secondary hyperparathyroidism, Hyperparathyroidism (Pediatric)
Treatment KHK7580, Cinacalcet Hydrochloride
Clinical Study IdentifierNCT03822507
SponsorKyowa Kirin Co., Ltd.
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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 Ca preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening
Change in prescribed conditions of dialysis (dialysate Ca concentration, prescribed dialysis time, and prescribed number of dialysis per week) within 2 weeks before screening
Treatment with bisphosphonates, denosumab or teriparatide within 24 weeks before screening
Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening
Severe heart disease (e.g., Class per New York Heart Association classification)
Severe hepatic dysfunction (e.g., treatment with antiviral therapy)
Uncontrolled hypertension and/or diabetes
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