Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism

Sanwa Kagaku Kenkyusho

Status and phase: Completed; Phase 2

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: Dose-adjusted SK-1403

Study type: Interventional

Funder types: Industry

Identifiers

NCT03226171

AJ1002

Details and patient eligibility

About

This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also assessed during this period. Patients who completed the first treatment period proceed to the second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and safety of SK-1403 are also assessed during this period.

Enrollment: 58 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Average serum PTH>240 pg/mL during 2 weeks 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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58 participants in 1 patient group

Dose-adjusted SK-1403

Experimental group

Treatment:

Drug: Dose-adjusted SK-1403