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Protocol Number7580-201
NCT Number(ClinicalTrials.gov Identfier)NCT03822507

2019-08-09 - 2022-06-30

Phase III

Terminated10

ICD-10E21.1

Secondary hyperparathyroidism, not elsewhere classified

ICD-9252.0

Hyperparathyroidism

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

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    Kyowa Hakko Kirin Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Der-Cherng Tarng Division of Nephrology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

4 Stop recruiting

Audit

None

Principal Investigator 吳家兆 Division of Nephrology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Junne-Ming Sung Division of Nephrology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Principal Investigator 黃志強 Division of Nephrology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 李建德 Division of Nephrology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 方華章 Division of Nephrology
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Ming-Ju Wu Division of Nephrology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator SHUEI-LIONG LIN Division of Nephrology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Hsi-Hsien Chen Division of Nephrology
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Yi wen chiu Division of Nephrology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Secondary Hyperparathyroidism

Objectives

The purpose of the study is to evaluate the efficacy and safety of KHK7580 orally administered once daily for 52 weeks in subjects with SHPT receiving hemodialysis in a randomized, double-blind, intra-subject dose-adjustment, parallel-group design with cinacalcet hydrochloride as an active control.

Test Drug

KHK7580

Active Ingredient

KHK7580 (Evocalcet)

Dosage Form

film coated tablet

Dosage

1 mg, 2 mg

Endpoints

Primary
• Mean percent change in intact PTH level from baseline in the evaluation period
Secondary
• Number and percentage of subjects achieving a mean intact PTH level of ≥150 pg/mL and
≤300 pg/mL in the evaluation period;
• Number and percentage of subjects achieving a mean percent decrease in intact PTH level
of ≥30% (percent change ≤−30%) from baseline in the evaluation period;
• Intact PTH level, corrected serum Ca level, and serum P level
Other
• Whole PTH level, intact FGF23 level, and corrected serum Ca-P product;
• Bone metabolic markers (BAP, TRACP-5b, and total P1NP)
Safety Endpoints
• TEAEs;
• TEAEs associated with upper gastrointestinal disorders;
• Laboratory values;
• Vital signs;
• 12-lead electrocardiogram (ECG)

Inclution 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; and
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) PTx and/or parathyroid intervention within 24 weeks before screening;
6) Severe heart disease (e.g., ≥Class III per New York Heart Association classification, see Appendix 1 of the protocol);
7) Severe hepatic dysfunction (e.g., treatment with antiviral therapy);
8) Uncontrolled hypertension and/or diabetes;
9) Pregnant, lactating, possibly pregnant women (women of childbearing potential with positive pregnancy test at screening or with negative pregnancy test but not using any contraceptive methods), or unwilling to use the adequate contraceptive
method(s) according to the physician’s instructions. Amenorrhea for ≥12 months after the last menstrual period without an alternative medical cause is considered as non-childbearing potential;
10) History of serious drug allergy. History of or current drug or alcohol dependence;
11) History of drug allergy to cinacalcet hydrochloride;
12) History of diagnosis and treatment of malignant tumor within 5 years before screening (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix);
13) 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;
14) Exposure to an investigational product in a prior clinical study of KHK7580;
15) Primary hyperparathyroidism;
16) Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.

The Estimated Number of Participants

  • Taiwan

    80 participants

  • Global

    400 participants

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