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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03822507
Other study ID # 7580-201
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT02549417 - Phase 3 Study of KHK7580 Phase 3
Completed NCT02549404 - Phase 3 Study of KHK7580 Phase 3
Not yet recruiting NCT02536287 - Comparison of Total Parathyroidectomy With and Without Autotransplantation Phase 3
Completed NCT02549391 - Phase 3 Study of KHK7580 Phase 2/Phase 3
Active, not recruiting NCT03023748 - Intravenous Paricalcitol in Chronic Hemodialysis Patients Phase 4
Withdrawn NCT01426724 - Effects of Vitamin D on Renal Blood Flow, Proteinuria and Inflammation in Patients With Chronic Kidney Disease N/A
Completed NCT01101113 - Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level Phase 4
Completed NCT01220050 - Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism Phase 2
Completed NCT00537979 - Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis Phase 4
Completed NCT00431496 - A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD) Phase 4
Completed NCT00379899 - ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis Phase 4
Completed NCT00073710 - Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium Phase 4
Completed NCT00117052 - SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism Phase 3
Completed NCT03626948 - SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis Phase 3
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Completed NCT01219855 - Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT) Phase 2/Phase 3
Completed NCT01224782 - Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT) N/A
Completed NCT00990704 - Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism Phase 2
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