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

Sanwa Kagaku Kenkyusho

Status and phase: Completed; Phase 3

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: SK-1403

Study type: Interventional

Funder types: Industry

Identifiers

NCT03626948

AJ1003

Details and patient eligibility

About

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

Enrollment: 157 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
• A history of severe drug allergy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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157 participants in 1 patient 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 (52 weeks), with individual dose adjustment.

Treatment:

Drug: SK-1403