Dose Adjustment Trial of SK-1403 in Hemodialysis Patients... | NCT03226171

Studies
Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism

NCT03226171

Sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

Status

Completed

Last Update Posted

Mar 15, 2019Actual

Enrollment

58Actual

Phase

Phase 2

Conditions

Secondary Hyperparathyroidism

Interventions

Dose-adjusted SK-1403

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 20, 2017Actual

Primary Completion Date

Sep 11, 2018Actual

Completion Date

Sep 11, 2018Actual

First Submitted Date

Jul 20, 2017

First Submission Date that Met QC Criteria

Jul 20, 2017

First Posted Date

Jul 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2019

Last Update Posted Date

Mar 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose-adjusted SK-1403	Experimental		Drug: Dose-adjusted SK-1403

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dose-adjusted SK-1403	Drug	SK-1403 is to be administered to patients for the whole treatment periods (52 weeks), with individual dose adjustment	Dose-adjusted SK-1403

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Rate of patients who achieved ≥ 30% or 50% reduction in serum PTH from baseline, respectively	Assessed by laboratory test value	18 weeks
Measured values and Changes from baseline in serum PTH, Ca, P, and serum Ca x P product

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Investigational site (there may be other sites in this country)		Tokyo			Japan

Condition Browse Module

MeSH Terms

ID	Term
D006962	Hyperparathyroidism, Secondary

Ancestor Terms

ID	Term
D006961	Hyperparathyroidism
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided