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

• Status: Completed
• Trial end date: 2020-02-05
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy of treatment with SK-1403 for 52 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

• A history of severe drug allergy