Phase 2 Study of KHK7580
Primary Purpose
Secondary Hyperparathyroidism
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Placebo
KHK7580 low dose
KHK7580 middle dose
KHK7580 high dose
KRN1493
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism
Eligibility Criteria
Inclusion Criteria:
- Subjects who have voluntarily consented to participate in this study
- Subjects with stable chronic renal disease receiving hemodialysis 3 times weekly for at least 12 weeks before screening
- Subjects with an intact Parathyroid hormone of >= 240 pg/mL at screening
Exclusion Criteria:
- Subjects with primary hyperparathyroidism
- Subjects who have received cinacalcet hydrochloride within 2 weeks before screening
- Subjects whose dose or dosing regimen of an active vitamin D drug or its derivative, phosphate binders, or calcium preparation has been changed or started within 2 weeks before screening.
- Subjects who have underwent parathyroidectomy and/or parathyroid intervention within 24 weeks before screening.
- Subjects with uncontrolled hypertension and/or diabetes
- Subjects with severe heart disease.
- Subjects with severe hepatic dysfunction.
- Subjects who have received any other investigational drug within 12 weeks before screening
- Other subjects unfit for participation in this study in the judgment of the investigator or sub investigator.
Sites / Locations
- For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Plascebo
KHK7580 low dose
KHK7580 middle dose
KHK7580 high dose
KRN1493
Arm Description
Outcomes
Primary Outcome Measures
The percent changes in intact Parathyroid hormone levels from baseline
Percent changes in intact Parathyroid hormone levels from baseline to end of administration period
Secondary Outcome Measures
Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus.
Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus from baseline to end of administrations period.
Safety
Number and types of adverse events
laboratory tests
vital signs
12-lead electrocardiogram
ophthalmological examination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02216656
Brief Title
Phase 2 Study of KHK7580
Official Title
A Randomized, Double-blind, Parallel-group, Dose-finding Study of KHK7580 for Secondary Hyperparathyroidism Patients Receiving Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (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 randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism patients receiving hemodialysis.
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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plascebo
Arm Type
Placebo Comparator
Arm Title
KHK7580 low dose
Arm Type
Experimental
Arm Title
KHK7580 middle dose
Arm Type
Experimental
Arm Title
KHK7580 high dose
Arm Type
Experimental
Arm Title
KRN1493
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
KHK7580 low dose
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
KHK7580 middle dose
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
KHK7580 high dose
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
KRN1493
Other Intervention Name(s)
cinacalcet
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
The percent changes in intact Parathyroid hormone levels from baseline
Description
Percent changes in intact Parathyroid hormone levels from baseline to end of administration period
Time Frame
Up to 3 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus.
Description
Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus from baseline to end of administrations period.
Time Frame
Up to 3 weeks
Title
Safety
Description
Number and types of adverse events
laboratory tests
vital signs
12-lead electrocardiogram
ophthalmological examination
Time Frame
Up to 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who have voluntarily consented to participate in this study
Subjects with stable chronic renal disease receiving hemodialysis 3 times weekly for at least 12 weeks before screening
Subjects with an intact Parathyroid hormone of >= 240 pg/mL at screening
Exclusion Criteria:
Subjects with primary hyperparathyroidism
Subjects who have received cinacalcet hydrochloride within 2 weeks before screening
Subjects whose dose or dosing regimen of an active vitamin D drug or its derivative, phosphate binders, or calcium preparation has been changed or started within 2 weeks before screening.
Subjects who have underwent parathyroidectomy and/or parathyroid intervention within 24 weeks before screening.
Subjects with uncontrolled hypertension and/or diabetes
Subjects with severe heart disease.
Subjects with severe hepatic dysfunction.
Subjects who have received any other investigational drug within 12 weeks before screening
Other subjects unfit for participation in this study in the judgment of the investigator or sub investigator.
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
Learn more about this trial
Phase 2 Study of KHK7580
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