Phase 3 Study of SK-1403

Phase 3 Study of SK-1403 ; Double-blinded Parallel Group in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis

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

Study Overview

• Status: Completed
• Conditions: Secondary Hyperparathyroidism
• Intervention / Treatment: Drug: SK-1403; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Investigational site (there may be other sites in this country)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: 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_COMPARATOR: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 weeks
Measured values and Changes from baseline in serum PTH	Assessed by laboratory test value; unit of measure (pg/mL)	24 weeks
Measured values and Changes from baseline in Ca	Assessed by laboratory test value; unit of measure (mg/dL)	24 weeks
Measured values and Changes from baseline in ionized Ca	Assessed by laboratory test value; unit of measure (mEq/dL)	24 weeks
Measured values and Changes from baseline in P	Assessed by laboratory test value; unit of measure (mg/dL)	24 weeks
Measured values and Changes from baseline in serum Ca x P product	Assessed by laboratory test value	24 weeks

Collaborators and Investigators

• Sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 21, 2019
• Primary Completion (ACTUAL): December 17, 2019
• Study Completion (ACTUAL): December 21, 2019

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (ACTUAL): January 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Parathyroid Diseases; Neoplastic Processes; Hyperparathyroidism; Neoplasm Metastasis; Hyperparathyroidism, Secondary
• Other Study ID Numbers: AJ1004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No