Back to resultsPhase 3 Study of KHK7580
Primary Purpose
Secondary Hyperparathyroidism
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KHK7580
KRN1493
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 hemodialysis 3 times weekly for at least 12 weeks before screening
- Mean intact PTH level of > 240 pg/ml at screening, at 2 weeks and 1 week before the start of study treatment
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 2
Arm Type
Experimental
Active Comparator
Arm Label
KHK7580
KRN1493
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
NCT ID
NCT02549391
First Posted
September 9, 2015
Last Updated
March 23, 2017
Sponsor
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02549391
Brief Title
Phase 3 Study of KHK7580
Official Title
Phase 3 Study of KHK7580 (A Randomized, Double-Blind, Intra-Subject Dose-Adjustment, Parallel-Group Study of KHK7580 and Cinacalcet Hydrochloride in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 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
The purpose of this study is to evaluate the efficacy and safety of KHK7580 orally administered once daily for 30 weeks in subjects with secondary hyperparathyroidism (SHPT) receiving hemodialysis in a randomized, double-blind, intra-subject dose-adjustment, parallel-group design with cinacalcet hydrochloride as an active control.
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, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
634 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KHK7580
Arm Type
Experimental
Arm Title
KRN1493
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
KHK7580
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
KRN1493
Other Intervention Name(s)
cinacalcet hydrochloride
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 28-30
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 28-30
Title
Mean percent change in the evaluation period in intact PTH level from baseline
Time Frame
Weeks 28-30
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 hemodialysis 3 times weekly for at least 12 weeks before screening
Mean intact PTH level of > 240 pg/ml at screening, at 2 weeks and 1 week before the start of study treatment
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
35176038
Citation
Shigematsu T, Asada S, Endo Y, Kawata T, Fukagawa M, Akizawa T. Evocalcet with vitamin D receptor activator treatment for secondary hyperparathyroidism. PLoS One. 2022 Feb 17;17(2):e0262829. doi: 10.1371/journal.pone.0262829. eCollection 2022.
Results Reference
derived
Learn more about this trial
Phase 3 Study of KHK7580
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