Phase 3 Study of SK-1403
Primary Purpose
Secondary Hyperparathyroidism
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
SK-1403
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism
Eligibility Criteria
Inclusion Criteria:
- Serum PTH>240 pg/mL at the screening
- Serum corrected Ca≧8.4 mg/dL at the screening
- Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration
Exclusion Criteria:
- Primary hyperparathyroidism
- Severe liver disease
- Severe Cardiac disease
- History or family history of long QT syndrome
- Malignant tumor
- Uncontrolled diabetes mellitus
- Uncontrolled hypertension
- History of severe drug allergy
Sites / Locations
- Investigational site (there may be other sites in this country)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SK-1403
Placebo
Arm Description
Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
Outcomes
Primary Outcome Measures
Rate of participants who achieved a mean serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL from 22 to 24 week.
Assessed by laboratory test value
Secondary Outcome Measures
Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point.
Assessed by laboratory test value
Measured values and Changes from baseline in serum PTH
Assessed by laboratory test value; unit of measure (pg/mL)
Measured values and Changes from baseline in Ca
Assessed by laboratory test value; unit of measure (mg/dL)
Measured values and Changes from baseline in ionized Ca
Assessed by laboratory test value; unit of measure (mEq/dL)
Measured values and Changes from baseline in P
Assessed by laboratory test value; unit of measure (mg/dL)
Measured values and Changes from baseline in serum Ca x P product
Assessed by laboratory test value
Full Information
NCT ID
NCT03801980
First Posted
January 8, 2019
Last Updated
March 6, 2020
Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03801980
Brief Title
Phase 3 Study of SK-1403
Official Title
Phase 3 Study of SK-1403 ; Double-blinded Parallel Group in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 21, 2019 (Actual)
Primary Completion Date
December 17, 2019 (Actual)
Study Completion Date
December 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with secondary hyperparathyroidism on maintenance 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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SK-1403
Arm Type
Experimental
Arm Description
Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
Intervention Type
Drug
Intervention Name(s)
SK-1403
Intervention Description
Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
Primary Outcome Measure Information:
Title
Rate of participants who achieved a mean serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL from 22 to 24 week.
Description
Assessed by laboratory test value
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point.
Description
Assessed by laboratory test value
Time Frame
24 weeks
Title
Measured values and Changes from baseline in serum PTH
Description
Assessed by laboratory test value; unit of measure (pg/mL)
Time Frame
24 weeks
Title
Measured values and Changes from baseline in Ca
Description
Assessed by laboratory test value; unit of measure (mg/dL)
Time Frame
24 weeks
Title
Measured values and Changes from baseline in ionized Ca
Description
Assessed by laboratory test value; unit of measure (mEq/dL)
Time Frame
24 weeks
Title
Measured values and Changes from baseline in P
Description
Assessed by laboratory test value; unit of measure (mg/dL)
Time Frame
24 weeks
Title
Measured values and Changes from baseline in serum Ca x P product
Description
Assessed by laboratory test value
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Serum PTH>240 pg/mL at the screening
Serum corrected Ca≧8.4 mg/dL at the screening
Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration
Exclusion Criteria:
Primary hyperparathyroidism
Severe liver disease
Severe Cardiac disease
History or family history of long QT syndrome
Malignant tumor
Uncontrolled diabetes mellitus
Uncontrolled hypertension
History of severe drug allergy
Facility Information:
Facility Name
Investigational site (there may be other sites in this country)
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Phase 3 Study of SK-1403
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