Phase 3 Study of SK-1403

Secondary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03801980
• Other study ID #: AJ1004
• Status: Completed
• Phase: Phase 3
• Start date: January 21, 2019
• Est. completion date: December 21, 2019

Study information

• Verified date: March 2020
• Source: Sanwa Kagaku Kenkyusho Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: December 21, 2019
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

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
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.

Locations

Country	Name	City	State
Japan	Investigational site (there may be other sites in this country)	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanwa Kagaku Kenkyusho Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

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