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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
  Purpose

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.


Condition Intervention
Secondary Hyperparathyroidism
 Drug: high or low dose alfacalcidol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Maintenance Therapy After Intravenous Maxacalcitol for Secondary Hyperparathyroidism

Resource links provided by NLM:

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Further study details as provided by Kumamoto University:

Primary Outcome Measures:
  • We evaluated the maintenance rate of the target iPTH level. [ Time Frame: 24 weeks after intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: January 2008
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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: 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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828347

Locations
Japan
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Kumamoto University
  More Information

No publications provided

Responsible Party: Masataka Adachi assistant professor, Kumamoto Univ.
ClinicalTrials.gov Identifier: NCT00828347     History of Changes
Other Study ID Numbers: KumaNeph2
Study First Received: January 22, 2009
Last Updated: January 29, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases
Maxacalcitol
Hydroxycholecalciferols
1-hydroxycholecalciferol
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Dermatologic Agents
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 23, 2013