Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia

Secondary Hyperparathyroidism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03822507
• Other study ID #: 7580-201
• Status: Completed
• Phase: Phase 3
• Start date: April 9, 2019
• Est. completion date: September 23, 2021

Study information

• Verified date: April 2022
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: September 23, 2021
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ? per New York Heart Association classification)

7. Severe hepatic dysfunction (e.g., treatment with antiviral therapy)

8. Uncontrolled hypertension and/or diabetes

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

Drug:
• KHK7580
oral administration
• Cinacalcet Hydrochloride
oral administration

Locations

Country	Name	City	State
China	Research site_29	Changsha
China	Research site_34	Dalian
China	Research site_25	Foshan
China	Research site_22	Guangzhou
China	Research site_23	Guangzhou
China	Research site_30	Guangzhou
China	Research site_28	Hefei
China	Research site_32	Nanjing
China	Research site_33	Nanjing
China	Research site_24	Shanghai
China	Research site_26	Shanghai
China	Research site_27	Shanghai
China	Research site_31	Wuxi
Hong Kong	Research site_11	Hong Kong
Korea, Republic of	Research site_21	Anyang
Korea, Republic of	Research site_13	Daegu
Korea, Republic of	Research site_15	Daegu
Korea, Republic of	Research site_12	Goyang
Korea, Republic of	Research site_18	Incheon
Korea, Republic of	Research site_14	Seoul
Korea, Republic of	Research site_17	Seoul
Korea, Republic of	Research site_19	Seoul
Korea, Republic of	Research site_20	Seoul
Korea, Republic of	Research site_16	Ulsan
Taiwan	Research site_2	Kaohsiung
Taiwan	Research site_3	Kaohsiung
Taiwan	Research site_5	Kaohsiung
Taiwan	Research site_9	Taichung
Taiwan	Research site_4	Tainan
Taiwan	Research site_7	Tainan
Taiwan	Research site_1	Taipei
Taiwan	Research site_10	Taipei
Taiwan	Research site_6	Taipei
Taiwan	Research site_8	Taipei

Sponsors (3)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.	Kyowa Hakko Kirin China Pharmaceutical Co., LTD., Kyowa Kirin Korea Co., Ltd.

Countries where clinical trial is conducted

China,  Hong Kong,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period		Week 50- Week 52
Secondary	Number of subjects achieving a mean intact PTH level of ?150pg/mL and ?300pg/mL in the evaluation period		Week 50- Week 52
Secondary	Percentage of subjects achieving a mean intact PTH level of ?150pg/mL and ?300pg/mL in the evaluation period		Week 50- Week 52
Secondary	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
Secondary	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
Secondary	Intact PTH level		Week 50- Week 52
Secondary	corrected serum Ca level		Week 50- Week 52
Secondary	serum P level		Week 50- Week 52