Back to resultsDose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism
Primary Purpose
Secondary Hyperparathyroidism
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Dose-adjusted SK-1403
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism
Eligibility Criteria
Inclusion Criteria:
- Average serum PTH>240 pg/mL during 2 weeks 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
Dose-adjusted SK-1403
Arm Description
Outcomes
Primary Outcome Measures
Rate of patients who achieved serum PTH between 60 pg/mL and 240 pg/mL, inclusive
Assessed by laboratory test value
Secondary Outcome Measures
Rate of patients who achieved ≥ 30% or 50% reduction in serum PTH from baseline, respectively
Assessed by laboratory test value
Measured values and Changes from baseline in serum PTH, Ca, P, and serum Ca x P product
Assessed by laboratory test value
Full Information
NCT ID
NCT03226171
First Posted
July 20, 2017
Last Updated
March 14, 2019
Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03226171
Brief Title
Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism
Official Title
Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
September 11, 2018 (Actual)
Study Completion Date
September 11, 2018 (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
This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also assessed during this period. Patients who completed the first treatment period proceed to the second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and safety of SK-1403 are also assessed during this period.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose-adjusted SK-1403
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dose-adjusted SK-1403
Intervention Description
SK-1403 is to be administered to patients for the whole treatment periods (52 weeks), with individual dose adjustment
Primary Outcome Measure Information:
Title
Rate of patients who achieved serum PTH between 60 pg/mL and 240 pg/mL, inclusive
Description
Assessed by laboratory test value
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Rate of patients who achieved ≥ 30% or 50% reduction in serum PTH from baseline, respectively
Description
Assessed by laboratory test value
Time Frame
18 weeks
Title
Measured values and Changes from baseline in serum PTH, Ca, P, and serum Ca x P product
Description
Assessed by laboratory test value
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Average serum PTH>240 pg/mL during 2 weeks 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
Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism
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