NCT03226171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 20, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2018

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

July 20, 2017

Last Update Submit

March 14, 2019

Conditions

Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

  • Rate of patients who achieved serum PTH between 60 pg/mL and 240 pg/mL, inclusive

    Assessed by laboratory test value

    18 weeks

Secondary Outcomes (2)

  • Rate of patients who achieved ≥ 30% or 50% reduction in serum PTH from baseline, respectively

    18 weeks

  • Measured values and Changes from baseline in serum PTH, Ca, P, and serum Ca x P product

    52 weeks

Study Arms (1)

Dose-adjusted SK-1403

EXPERIMENTAL
Drug: Dose-adjusted SK-1403

Interventions

Dose-adjusted SK-1403DRUG

SK-1403 is to be administered to patients for the whole treatment periods (52 weeks), with individual dose adjustment

Dose-adjusted SK-1403

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational site (there may be other sites in this country)

Tokyo, Japan

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 21, 2017

Study Start

June 20, 2017

Primary Completion

September 11, 2018

Study Completion

September 11, 2018

Last Updated

March 15, 2019

Record last verified: 2019-03

Locations

JP(1)