Phase 3 Study of SK-1403

• Status: Completed
• Trial end date: 2019-12-21
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.

Criteria

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