NCT03801980

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

January 21, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2019

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2019

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

January 8, 2019

Last Update Submit

March 6, 2020

Conditions

Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

  • Rate of participants who achieved a mean serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL from 22 to 24 week.

    Assessed by laboratory test value

    24 weeks

Secondary Outcomes (6)

  • Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point.

    24 weeks

  • Measured values and Changes from baseline in serum PTH

    24 weeks

  • Measured values and Changes from baseline in Ca

    24 weeks

  • Measured values and Changes from baseline in ionized Ca

    24 weeks

  • Measured values and Changes from baseline in P

    24 weeks

  • +1 more secondary outcomes

Study Arms (2)

SK-1403

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

SK-1403DRUG

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.

SK-1403
PlaceboDRUG

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.

Placebo

Eligibility Criteria

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

You may qualify if:

  • 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

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
  • 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

Related Publications (1)

  • Shigematsu T, Koiwa F, Isaka Y, Fukagawa M, Hagita K, Watanabe YS, Honda D, Akizawa T. Efficacy and Safety of Upacicalcet in Hemodialysis Patients with Secondary Hyperparathyroidism: A Randomized Placebo-Controlled Trial. Clin J Am Soc Nephrol. 2023 Oct 1;18(10):1300-1309. doi: 10.2215/CJN.0000000000000253. Epub 2023 Sep 11.

    PMID: 37696667DERIVED

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2019

First Posted

January 14, 2019

Study Start

January 21, 2019

Primary Completion

December 17, 2019

Study Completion

December 21, 2019

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations

JP(1)