Phase 3 Study of SK-1403

Phase 3

Completed

• Conditions: Secondary Hyperparathyroidism
• Interventions: Drug: SK-1403; Drug: Placebo

• Registration Number: NCT03801980
• Lead Sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-09
• Study First Posted: 2019-01-14
• Study Start: 2019-01-21
• Primary Completion: 2019-12-17
• Study Completion: 2019-12-21
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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
• History of severe drug allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SK-1403	SK-1403	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.
Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Rate of participants who achieved a mean serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL from 22 to 24 week.	24 weeks	Assessed by laboratory test value

Secondary Outcome Measures

Name	Time	Method
Measured values and Changes from baseline in ionized Ca	24 weeks	Assessed by laboratory test value; unit of measure (mEq/dL)
Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point.	24 weeks	Assessed by laboratory test value
Measured values and Changes from baseline in serum PTH	24 weeks	Assessed by laboratory test value; unit of measure (pg/mL)
Measured values and Changes from baseline in Ca	24 weeks	Assessed by laboratory test value; unit of measure (mg/dL)
Measured values and Changes from baseline in P	24 weeks	Assessed by laboratory test value; unit of measure (mg/dL)
Measured values and Changes from baseline in serum Ca x P product	24 weeks	Assessed by laboratory test value

Trial Locations

Locations (1)

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