Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia

Phase 3

Completed

• Conditions: Secondary Hyperparathyroidism
• Interventions: Drug: Cinacalcet Hydrochloride; Drug: KHK7580

• Registration Number: NCT03822507
• Lead Sponsor: Kyowa 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-30
• Study Start: 2019-04-09
• Primary Completion: 2021-09-23
• Study Completion: 2021-09-23
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 404

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cinacalcet 25mg-100mg	Cinacalcet Hydrochloride	-
KHK7580 1mg-12mg	KHK7580	-

Primary Outcome Measures

Name	Time	Method
Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period	Week 50- Week 52

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period	Week 50- Week 52
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
Number of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period	Week 50- Week 52
Intact PTH level	Week 50- Week 52
corrected serum Ca level	Week 50- Week 52
serum P level	Week 50- Week 52
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

Trial Locations

Locations (34)

Research site_3; 🇨🇳 Kaohsiung, Taiwan

Research site_5; 🇨🇳 Kaohsiung, Taiwan

Research site_6; 🇨🇳 Taipei, Taiwan

Research site_7; 🇨🇳 Tainan, Taiwan

Research site_17; 🇰🇷 Seoul, Korea, Republic of

Research site_18; 🇰🇷 Incheon, Korea, Republic of

Research site_16; 🇰🇷 Ulsan, Korea, Republic of

Research site_20; 🇰🇷 Seoul, Korea, Republic of

Research site_1; 🇨🇳 Taipei, Taiwan

Research site_9; 🇨🇳 Taichung, Taiwan

Research site_19; 🇰🇷 Seoul, Korea, Republic of

Research site_4; 🇨🇳 Tainan, Taiwan

Research site_22; 🇨🇳 Guangzhou, China

Research site_34; 🇨🇳 Dalian, China

Research site_25; 🇨🇳 Foshan, China

Research site_29; 🇨🇳 Changsha, China

Research site_23; 🇨🇳 Guangzhou, China

Research site_26; 🇨🇳 Shanghai, China

Research site_30; 🇨🇳 Guangzhou, China

Research site_28; 🇨🇳 Hefei, China

Research site_24; 🇨🇳 Shanghai, China

Research site_27; 🇨🇳 Shanghai, China

Research site_31; 🇨🇳 Wuxi, China

Research site_12; 🇰🇷 Goyang, Korea, Republic of

Research site_21; 🇰🇷 Anyang, Korea, Republic of

Research site_15; 🇰🇷 Daegu, Korea, Republic of

Research site_13; 🇰🇷 Daegu, Korea, Republic of

Research site_10; 🇨🇳 Taipei, Taiwan

Research site_14; 🇰🇷 Seoul, Korea, Republic of

Research site_8; 🇨🇳 Taipei, Taiwan

Research site_2; 🇨🇳 Kaohsiung, Taiwan

Research site_32; 🇨🇳 Nanjing, China

Research site_33; 🇨🇳 Nanjing, China

Research site_11; 🇭🇰 Hong Kong, Hong Kong