Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Masataka Adachi, Kumamoto University
ClinicalTrials.gov Identifier:
NCT00828347
First received: January 22, 2009
Last updated: December 16, 2015
Last verified: December 2015

January 22, 2009
December 16, 2015
January 2008
July 2009   (final data collection date for primary outcome measure)
Number of Participants With iPTH Levels Maintained at the Target Levels of 60-180 pg/mL iPTH Level [ Time Frame: Participants were followed for 24 weeks ] [ Designated as safety issue: Yes ]
We evaluated the maintenance rate of the target iPTH level. [ Time Frame: 24 weeks after intervention ] [ Designated as safety issue: Yes ]
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.

Chronic kidney disease (CKD) causes various bone mineral disorders, which have recently been named CKD mineral and bone disorder (CKD-MBD). CKD-MBD presents a spectrum of skeletal abnormalities ranging from high bone turnover state such as osteitis fibrosa, which is seen with SHPT, to states of low bone turnover, which includes osteomalacia and adynamic bone disease. This disease not only increases the risk of cardiovascular disease and mortality, but also increases the risk of fracture. Therefore, it is important to correct the serum inorganic phosphorus (Pi), calcium (Ca) and parathyroid hormone (PTH) levels in dialysis patients, to achieve both appropriate bone turnover and to improve mortality.

The Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines recommend that the target range of iPTH level for vitamin D therapy should be set at 150-300 pg/mL. In Japan, the mortality risk was significantly lower in the group of patients with iPTH levels < 120 pg/mL than in the standard group set at 180 pg/mL < iPTH < 360 pg/mL, and lowest in the group of patients with 60 pg/mL < iPTH < 120 pg/mL . Based on these findings, Japanese guideline recommend that the target range of iPTH should be set at 60-180 pg/mL .

The efficacies of various oral and intravenous vitamin D preparations for treating SHPT in hemodialysis patients have been reported. and oral or intravenous vitamin D pulse therapy has been clinically applied, especially for patients with severe SHPT.

Up to now, the effectiveness of an oral daily alfacalcidol on SHPT has been confirmed at the dose of 0.25-0.5 μg /day (average 0.364μg /day), 0.5 μg /day, and 1.0 μg /day. The effective dose of OCT has also been verified, and furthermore, it has also been reported that intravenous vitamin D was more effective than oral vitamin D for suppressing PTH secretion. Accordingly, at present intravenous vitamin D therapy is the standard treatment for SHPT, and there are established protocols with regard to dosage and administration. However, no protocols have been established for maintenance therapy using intravenous or oral vitamin D preparations after the control of iPTH target range has been achieved.

Therefore, the present study compared the efficacy of two maintenance therapy protocols for patients with SHPT who responded to initial OCT therapy, resulting in the control of iPTH to <150pg/mL. One was oral administration of alfacalcidol (an oral vitamin D preparation) at a dose of 1.0 μg/day (higher-dose group) and the other was at a dose of 0.25 μg/day (lower-dose group), both of which are clinically effective doses for HD patients with SHPT.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Secondary Hyperparathyroidism
  • Drug: 1.0 μg/day Alfacalcidol
    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.
    Other Name: One alpha
  • Drug: 0.25 μg/day Alfacalcidol
    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.
    Other Name: One alpha
  • 1.0 μg/day Alfacalcidol
    Alfacalcidol 1.0 μg capsule by mouth, every day for 6 months
    Intervention: Drug: 1.0 μg/day Alfacalcidol
  • 0.25 μg/day Alfacalcidol
    Alfacalcidol 0.25 μg capsule by mouth, every day for 6 months
    Intervention: Drug: 0.25 μg/day Alfacalcidol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
July 2009
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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00828347
KumaNeph2
Yes
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Masataka Adachi, Kumamoto University
Kumamoto University
Not Provided
Principal Investigator: Masataka Adachi, M.D., Ph.D. Department nephrology Kumamoto University
Kumamoto University
December 2015

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