Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

There are still no established protocols for maintenance therapy with intravenous or oral vitamin D preparations after the iPTH target has been achieved.

Therefore, the present study compared the efficacy of two maintenance therapy protocols, i.e., oral administration of alfacalcidol (an oral vitamin D preparation) at a dose of 1.0 ug/day (higher-dose group) or at a dose of 0.25 ug/day (lower-dose group), in patients with secondary hyperparathyroidism who responded to initial maxacalcitol therapy, resulting in the control of iPTH to < 150 pg/mL.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kumamoto University
• Treatments: Alfacalcidol; Hydroxycholecalciferols; Maxacalcitol

Criteria

Inclusion Criteria:

• Clinical diagnosis of secondary hyperparathyroidism (iPTH >200 pg/mL to <500 pg/mL)

• Serum Ca < 11.0 mg/dL, and serum P < 7.0 mg/dL.

• At least one year of regular hemodialysis therapy

Exclusion Criteria:

• Patients with a history of hypersensitivity to any ingredient of maxacalcitol

• Patients who had received parathyroidectomy