SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis

Phase 3

Completed

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

• Registration Number: NCT03626948
• Lead Sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.

Brief Summary

To evaluate the safety and efficacy of treatment with SK-1403 for 52 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-08
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-13
• Study Start: 2018-09-13
• Primary Completion: 2020-02-04
• Study Completion: 2020-02-05
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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
• A history of severe drug allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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 (52 weeks), with individual dose adjustment.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events or adverse drug reactions	52 weeks	Number of participants with adverse events or adverse drug reactions

Secondary Outcome Measures

Name	Time	Method
Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point	52 weeks	Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point; Assessed by laboratory test value
Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product	52 weeks	Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product; Assessed by laboratory test value

Trial Locations

Locations (1)

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