Back to resultsSK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis
Primary Purpose
Secondary Hyperparathyroidism
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
SK-1403
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
- A history of severe drug allergy
Sites / Locations
- Investigational site (there may be other sites in this country)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SK-1403
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 (52 weeks), with individual dose adjustment.
Outcomes
Primary Outcome Measures
Number of participants with adverse events or adverse drug reactions
Number of participants with adverse events or adverse drug reactions
Secondary Outcome Measures
Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point
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, Ca, ionized Ca, P, and serum Ca x P product
Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product; Assessed by laboratory test value
Full Information
NCT ID
NCT03626948
First Posted
August 8, 2018
Last Updated
March 6, 2020
Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03626948
Brief Title
SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis
Official Title
SK-1403 Long-term Treatment Study - Long-term Study 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
September 13, 2018 (Actual)
Primary Completion Date
February 4, 2020 (Actual)
Study Completion Date
February 5, 2020 (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 safety and efficacy of treatment with SK-1403 for 52 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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
157 (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 (52 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 (52 weeks), with individual dose adjustment.
Primary Outcome Measure Information:
Title
Number of participants with adverse events or adverse drug reactions
Description
Number of participants with adverse events or adverse drug reactions
Time Frame
52 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
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
Time Frame
52 weeks
Title
Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product
Description
Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product; Assessed by laboratory test value
Time Frame
52 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
A 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
SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis
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