Overview

This trial is active, not recruiting.

Condition secondary hyperparathyroidism
Treatment high or low dose alfacalcidol
Sponsor Kumamoto University
Start date January 2008
End date July 2009
Trial size 50 participants
Trial identifier NCT00828347, KumaNeph2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
high or low dose alfacalcidol
We compared the efficacy of two protocols for maintenance therapy, which were oral administration of alfacalcidol at a dose of 1.0 ug/day or at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
(Experimental)
oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
high or low dose alfacalcidol
We compared the efficacy of two protocols for maintenance therapy, which were oral administration of alfacalcidol at a dose of 1.0 ug/day or at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.

Primary Outcomes

Measure
We evaluated the maintenance rate of the target iPTH level.
time frame: 24 weeks after intervention

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Study of Maintenance Therapy After Intravenous Maxacalcitol for Secondary Hyperparathyroidism
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by Kumamoto University.