Phase 3 Study of SK-1403

Sanwa Kagaku Kenkyusho

Status and phase: Completed; Phase 3

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: Placebo; Drug: SK-1403

Study type: Interventional

Funder types: Industry

Identifiers

NCT03801980

AJ1004

Details and patient eligibility

About

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

Enrollment: 153 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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153 participants in 2 patient groups, including a placebo group

SK-1403

Experimental group

Description:

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.

Treatment:

Drug: SK-1403

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo