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Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)

Primary Purpose

Secondary Hyperparathyroidism

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
1.0 μg/day Alfacalcidol
0.25 μg/day Alfacalcidol
Sponsored by
Kumamoto University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kumamoto University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1.0 μg/day Alfacalcidol

0.25 μg/day Alfacalcidol

Arm Description

Alfacalcidol 1.0 μg capsule by mouth, every day for 6 months

Alfacalcidol 0.25 μg capsule by mouth, every day for 6 months

Outcomes

Primary Outcome Measures

Number of Participants With iPTH Levels Maintained at the Target Levels of 60-180 pg/mL iPTH Level

Secondary Outcome Measures

Full Information

First Posted
January 22, 2009
Last Updated
December 16, 2015
Sponsor
Kumamoto University
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1. Study Identification

Unique Protocol Identification Number
NCT00828347
Brief Title
Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)
Official Title
A Study of Maintenance Therapy After Intravenous Maxacalcitol for Secondary Hyperparathyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kumamoto University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.0 μg/day Alfacalcidol
Arm Type
Other
Arm Description
Alfacalcidol 1.0 μg capsule by mouth, every day for 6 months
Arm Title
0.25 μg/day Alfacalcidol
Arm Type
Other
Arm Description
Alfacalcidol 0.25 μg capsule by mouth, every day for 6 months
Intervention Type
Drug
Intervention Name(s)
1.0 μg/day Alfacalcidol
Other Intervention Name(s)
One alpha
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
0.25 μg/day Alfacalcidol
Other Intervention Name(s)
One alpha
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masataka Adachi, M.D., Ph.D.
Organizational Affiliation
Department nephrology Kumamoto University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan

12. IPD Sharing Statement

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Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)

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