Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 3 Study of SK-1403

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03801980
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Sanwa Kagaku Kenkyusho Co., Ltd.

Tracking Information
First Submitted Date  ICMJE January 8, 2019
First Posted Date  ICMJE January 14, 2019
Last Update Posted Date March 9, 2020
Actual Study Start Date  ICMJE January 21, 2019
Actual Primary Completion Date December 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2019)
Rate of participants who achieved a mean serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL from 22 to 24 week. [ Time Frame: 24 weeks ]
Assessed by laboratory test value
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2019)
  • Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point. [ Time Frame: 24 weeks ]
    Assessed by laboratory test value
  • Measured values and Changes from baseline in serum PTH [ Time Frame: 24 weeks ]
    Assessed by laboratory test value; unit of measure (pg/mL)
  • Measured values and Changes from baseline in Ca [ Time Frame: 24 weeks ]
    Assessed by laboratory test value; unit of measure (mg/dL)
  • Measured values and Changes from baseline in ionized Ca [ Time Frame: 24 weeks ]
    Assessed by laboratory test value; unit of measure (mEq/dL)
  • Measured values and Changes from baseline in P [ Time Frame: 24 weeks ]
    Assessed by laboratory test value; unit of measure (mg/dL)
  • Measured values and Changes from baseline in serum Ca x P product [ Time Frame: 24 weeks ]
    Assessed by laboratory test value
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study of SK-1403
Official Title  ICMJE Phase 3 Study of SK-1403 ; Double-blinded Parallel Group in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis
Brief Summary To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Secondary Hyperparathyroidism
Intervention  ICMJE
  • Drug: SK-1403
    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.
  • Drug: Placebo
    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.
Study Arms  ICMJE
  • Experimental: SK-1403
    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: Drug: SK-1403
  • Placebo Comparator: Placebo
    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: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2019)
153
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2019)
150
Actual Study Completion Date  ICMJE December 21, 2019
Actual Primary Completion Date December 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03801980
Other Study ID Numbers  ICMJE AJ1004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanwa Kagaku Kenkyusho Co., Ltd.
Study Sponsor  ICMJE Sanwa Kagaku Kenkyusho Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sanwa Kagaku Kenkyusho Co., Ltd.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP