Back to resultsPhase 3 Study of KHK7580
Primary Purpose
Secondary Hyperparathyroidism
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KHK7580
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism
Eligibility Criteria
Inclusion Criteria:
- Personally submitted written voluntary informed consent to participate in the study
- Stable chronic renal disease treated with peritoneal dialysis for at least 16 weeks before screening
- Intact PTH level of > 240 pg/ml at screening
Exclusion Criteria:
- Treatment with cinacalcet hydrochloride within 2 weeks before screening;
- Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening;
- Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening;
- Severe heart disease;
- Severe hepatic dysfunction;
- Uncontrolled hypertension and/or diabetes;
- 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;
- Primary hyperparathyroidism;
- Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.
Sites / Locations
- For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KHK7580
Arm Description
Outcomes
Primary Outcome Measures
Percentage of subjects in the evaluation period achieving a mean intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL
Secondary Outcome Measures
Percentage of subjects in the evaluation period achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline
Mean percent change in the evaluation period in intact PTH level from baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02549417
Brief Title
Phase 3 Study of KHK7580
Official Title
Phase 3 Study of KHK7580 (A Clinical Study of KHK7580 in Subjects With Secondary Hyperparathyroidism Receiving Peritoneal Dialysis)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 29, 2015 (Actual)
Primary Completion Date
December 22, 2016 (Actual)
Study Completion Date
December 22, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to evaluate efficacy and safety of KHK7580 orally administered once daily for 32 weeks for patients with secondary hyperparathyroidism receiving peritoneal dialysis. After 32-week treatment period, the subjects will receive KHK7580 in the 20-week extension period to evaluate long-term safety and efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KHK7580
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KHK7580
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Percentage of subjects in the evaluation period achieving a mean intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL
Time Frame
Weeks 30-32
Secondary Outcome Measure Information:
Title
Percentage of subjects in the evaluation period achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline
Time Frame
Weeks 30-32
Title
Mean percent change in the evaluation period in intact PTH level from baseline
Time Frame
Weeks 30-32
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Personally submitted written voluntary informed consent to participate in the study
Stable chronic renal disease treated with peritoneal dialysis for at least 16 weeks before screening
Intact PTH level of > 240 pg/ml at screening
Exclusion Criteria:
Treatment with cinacalcet hydrochloride within 2 weeks before screening;
Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening;
Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening;
Severe heart disease;
Severe hepatic dysfunction;
Uncontrolled hypertension and/or diabetes;
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;
Primary hyperparathyroidism;
Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
30955188
Citation
Tsuruya K, Shimazaki R, Fukagawa M, Akizawa T; Evocalcet Study Group. Efficacy and safety of evocalcet in Japanese peritoneal dialysis patients. Clin Exp Nephrol. 2019 Jun;23(6):739-748. doi: 10.1007/s10157-019-01692-y. Epub 2019 Apr 6. Erratum In: Clin Exp Nephrol. 2019 Jul 5;:
Results Reference
derived
Learn more about this trial
Phase 3 Study of KHK7580
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