CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
1.0 μg/day Alfacalcidol +1 moredrug
Likely dose
1.0 μg/day Alfacalcidolfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00828347
NCT00828347N/ACompleted

A Study of Maintenance Therapy After Intravenous Maxacalcitol for Secondary Hyperparathyroidism

Kumamoto University·interventional·Posted Jan 23, 2009·Updated Jan 25, 2016

In Brief

A clinical study evaluating 1.0 μg/day Alfacalcidol and 0.25 μg/day Alfacalcidol for Secondary Hyperparathyroidism. Completed, enrolled 35 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 23, 2009
Enrollment StartJan 1, 2008
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.4 years ago

Interventions

1.0 μg/day Alfacalcidoldrug

We compared the efficacy of two protocols for maintenance therapy, which were oral administration of alfacalcidol at a dose of 1.0 μg/day in patients whose iPTH level was controlled to \< 150 pg/mL by initial maxacalcitol therapy.

0.25 μg/day Alfacalcidoldrug

We compared the efficacy of two protocols for maintenance therapy, which were oral administration of alfacalcidol at a dose of 0.25 μg/day in patients whose iPTH level was controlled to \< 150 pg/mL by initial maxacalcitol therapy.