Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Kumamoto University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Kumamoto University
ClinicalTrials.gov Identifier:
NCT00828347
First received: January 22, 2009
Last updated: January 29, 2009
Last verified: January 2009

January 22, 2009
January 29, 2009
January 2008
July 2009   (final data collection date for primary outcome measure)
We evaluated the maintenance rate of the target iPTH level. [ Time Frame: 24 weeks after intervention ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00828347 on ClinicalTrials.gov Archive Site
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Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)
A Study of Maintenance Therapy After Intravenous Maxacalcitol for Secondary Hyperparathyroidism

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.

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Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Secondary Hyperparathyroidism
Drug: 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: high dose alfacalcidol
    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.
    Intervention: Drug: high or low dose alfacalcidol
  • Experimental: low dose alfacalcidol
    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.
    Intervention: Drug: high or low dose alfacalcidol
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
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July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00828347
KumaNeph2
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Masataka Adachi assistant professor, Kumamoto Univ.
Kumamoto University
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Kumamoto University
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP