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Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia

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ClinicalTrials.gov Identifier: NCT03822507
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Collaborators:
Kyowa Hakko Kirin China Pharmaceutical Co., LTD.
Kyowa Hakko Kirin Korea Co., Ltd.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism Drug: KHK7580 Drug: Cinacalcet Hydrochloride Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: KHK7580 1mg-12mg Drug: KHK7580
oral administration

Active Comparator: Cinacalcet 25mg-100mg Drug: Cinacalcet Hydrochloride
oral administration




Primary Outcome Measures :
  1. Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period [ Time Frame: Week 50- Week 52 ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822507


Contacts
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Contact: Kyowa Hakko Kirin Co., Ltd. +81-80-1045-1371 clinical.info@kyowa-kirin.co.jp

Locations
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China
Research site_29 Not yet recruiting
Changsha, China
Research site_34 Not yet recruiting
Dalian, China
Research site_25 Not yet recruiting
Foshan, China
Research site_22 Not yet recruiting
Guangzhou, China
Research site_23 Not yet recruiting
Guangzhou, China
Research site_30 Not yet recruiting
Guangzhou, China
Research site_28 Not yet recruiting
Hefei, China
Research site_32 Not yet recruiting
Nanjing, China
Research site_33 Not yet recruiting
Nanjing, China
Research site_24 Not yet recruiting
Shanghai, China
Research site_26 Not yet recruiting
Shanghai, China
Research site_27 Not yet recruiting
Shanghai, China
Research site_31 Not yet recruiting
Wuxi, China
Hong Kong
Research site_11 Not yet recruiting
Hong Kong, Hong Kong
Korea, Republic of
Research site_21 Not yet recruiting
Anyang, Korea, Republic of
Research site_13 Not yet recruiting
Daegu, Korea, Republic of
Research site_15 Not yet recruiting
Daegu, Korea, Republic of
Research site_12 Not yet recruiting
Goyang, Korea, Republic of
Research site_18
Incheon, Korea, Republic of
Research site_14 Not yet recruiting
Seoul, Korea, Republic of
Research site_17 Not yet recruiting
Seoul, Korea, Republic of
Research site_19 Not yet recruiting
Seoul, Korea, Republic of
Research site_20 Not yet recruiting
Seoul, Korea, Republic of
Research site_16 Not yet recruiting
Ulsan, Korea, Republic of
Taiwan
Research site_2 Not yet recruiting
Kaohsiung, Taiwan
Research site_3 Not yet recruiting
Kaohsiung, Taiwan
Research site_5 Not yet recruiting
Kaohsiung, Taiwan
Research site_9 Not yet recruiting
Taichung, Taiwan
Research site_4 Not yet recruiting
Tainan, Taiwan
Research site_7 Not yet recruiting
Tainan, Taiwan
Research site_10 Not yet recruiting
Taipei, Taiwan
Research site_1 Not yet recruiting
Taipei, Taiwan
Research site_6 Not yet recruiting
Taipei, Taiwan
Research site_8 Not yet recruiting
Taipei, Taiwan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
Kyowa Hakko Kirin China Pharmaceutical Co., LTD.
Kyowa Hakko Kirin Korea Co., Ltd.

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Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT03822507     History of Changes
Other Study ID Numbers: 7580-201
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases
Cinacalcet
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists