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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 22, 2009
Last Updated Date	January 29, 2009
Start Date ^ICMJE	January 2008
Estimated Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 22, 2009)	We evaluated the maintenance rate of the target iPTH level. [ Time Frame: 24 weeks after intervention ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00828347 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)
Official Title ^ICMJE	A Study of Maintenance Therapy After Intravenous Maxacalcitol for Secondary Hyperparathyroidism
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Secondary Hyperparathyroidism
Intervention ^ICMJE	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.
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	50
Completion Date	Not Provided
Estimated Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT00828347
Other Study ID Numbers ^ICMJE	KumaNeph2
Has Data Monitoring Committee	Not Provided
Responsible Party	Masataka Adachi assistant professor, Kumamoto Univ.
Study Sponsor ^ICMJE	Kumamoto University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Kumamoto University
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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