Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)
This trial is active, not recruiting.
|Treatment||high or low dose alfacalcidol|
|Start date||January 2008|
|End date||July 2009|
|Trial size||50 participants|
|Trial identifier||NCT00828347, KumaNeph2|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
We evaluated the maintenance rate of the target iPTH level.
time frame: 24 weeks after intervention
Male or female participants at least 18 years old.
- 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
- Patients with a history of hypersensitivity to any ingredient of maxacalcitol
- Patients who had received parathyroidectomy
|Official title||A Study of Maintenance Therapy After Intravenous Maxacalcitol for Secondary Hyperparathyroidism|
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