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

Phase 2

Completed

• Conditions: Secondary Hyperparathyroidism
• Interventions: Drug: Dose-adjusted SK-1403

• Registration Number: NCT03226171
• Lead Sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.

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 available

Study Timeline

• Study Start: 2017-06-20
• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-21
• Primary Completion: 2018-09-11
• Study Completion: 2018-09-11
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose-adjusted SK-1403	Dose-adjusted SK-1403	-

Primary Outcome Measures

Name	Time	Method
Rate of patients who achieved serum PTH between 60 pg/mL and 240 pg/mL, inclusive	18 weeks	Assessed by laboratory test value

Secondary Outcome Measures

Name	Time	Method
Rate of patients who achieved ≥ 30% or 50% reduction in serum PTH from baseline, respectively	18 weeks	Assessed by laboratory test value
Measured values and Changes from baseline in serum PTH, Ca, P, and serum Ca x P product	52 weeks	Assessed by laboratory test value

Trial Locations

Locations (1)

Investigational site (there may be other sites in this country); 🇯🇵 Tokyo, Japan