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SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis

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: NCT03626948
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Sanwa Kagaku Kenkyusho Co., Ltd.

Brief Summary:
To evaluate the safety and efficacy of treatment with SK-1403 for 52 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SK-1403 Long-term Treatment Study - Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis -
Actual Study Start Date : September 13, 2018
Actual Primary Completion Date : February 4, 2020
Actual Study Completion Date : February 5, 2020

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 (52 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 (52 weeks), with individual dose adjustment.




Primary Outcome Measures :
  1. Number of participants with adverse events or adverse drug reactions [ Time Frame: 52 weeks ]
    Number of participants with adverse events or adverse drug reactions


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: 52 weeks ]
    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

  2. Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product [ Time Frame: 52 weeks ]
    Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product; 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
  • A 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): NCT03626948


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: NCT03626948    
Other Study ID Numbers: AJ1003
First Posted: August 13, 2018    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