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Completed

NCT Number: NCT03822507

Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia

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.

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Key information

Conditions

Secondary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research site_29, Changsha, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Ⅲ per New York Heart Association classification)
  • Severe hepatic dysfunction (e.g., treatment with antiviral therapy)
  • Uncontrolled hypertension and/or diabetes

Treatment and study plan

KHK7580

Drug

oral administration

cinacalcet hydrochloride

Drug

oral administration

Primary outcomes

  1. Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period

    Time frame: Week 50- Week 52

Secondary outcomes

  1. Number of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period

    Time frame: Week 50- Week 52

  2. Percentage of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period

    Time frame: Week 50- Week 52

  3. Number of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period

    Time frame: Week 50- Week 52

  4. Percentage of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period

    Time frame: Week 50- Week 52

  5. Intact PTH level

    Time frame: Week 50- Week 52

  6. corrected serum Ca level

    Time frame: Week 50- Week 52

  7. serum P level

    Time frame: Week 50- Week 52

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Collaborators

  • Kyowa Kirin China Pharmaceutical Co., Ltd.
  • Kyowa Kirin Korea Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 30, 2019
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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