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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.

Brief Summary:
To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.

Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism Drug: SK-1403 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of SK-1403 ; Double-blinded Parallel Group in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis
Actual Study Start Date : January 21, 2019
Actual Primary Completion Date : December 17, 2019
Actual Study Completion Date : December 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Measured values and Changes from baseline in serum PTH [ Time Frame: 24 weeks ]
    Assessed by laboratory test value; unit of measure (pg/mL)

  3. Measured values and Changes from baseline in Ca [ Time Frame: 24 weeks ]
    Assessed by laboratory test value; unit of measure (mg/dL)

  4. Measured values and Changes from baseline in ionized Ca [ Time Frame: 24 weeks ]
    Assessed by laboratory test value; unit of measure (mEq/dL)

  5. Measured values and Changes from baseline in P [ Time Frame: 24 weeks ]
    Assessed by laboratory test value; unit of measure (mg/dL)

  6. Measured values and Changes from baseline in serum Ca x P product [ Time Frame: 24 weeks ]
    Assessed by laboratory test value



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801980


Locations
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Japan
Investigational site (there may be other sites in this country)
Tokyo, Japan
Sponsors and Collaborators
Sanwa Kagaku Kenkyusho Co., Ltd.

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Responsible Party: Sanwa Kagaku Kenkyusho Co., Ltd.
ClinicalTrials.gov Identifier: NCT03801980    
Other Study ID Numbers: AJ1004
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases