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Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00828347
Recruitment Status : Completed
First Posted : January 23, 2009
Results First Posted : January 25, 2016
Last Update Posted : January 25, 2016
Sponsor:
Information provided by (Responsible Party):
Masataka Adachi, Kumamoto University

Tracking Information
First Submitted Date  ICMJE January 22, 2009
First Posted Date  ICMJE January 23, 2009
Results First Submitted Date  ICMJE July 5, 2011
Results First Posted Date  ICMJE January 25, 2016
Last Update Posted Date January 25, 2016
Study Start Date  ICMJE January 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2015)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2009)
We evaluated the maintenance rate of the target iPTH level. [ Time Frame: 24 weeks after intervention ]
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Secondary Hyperparathyroidism
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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 Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2015)
35
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2009)
50
Actual Study Completion Date  ICMJE July 2009
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00828347
Other Study ID Numbers  ICMJE KumaNeph2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Masataka Adachi, Kumamoto University
Study Sponsor  ICMJE Kumamoto University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Masataka Adachi, M.D., Ph.D. Department nephrology Kumamoto University
PRS Account Kumamoto University
Verification Date December 2015

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