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SK-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
Sanwa Kagaku Kenkyusho Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 8, 2018
Last Updated
March 6, 2020
Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
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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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