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
  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: 1.0 μg/day Alfacalcidol
Drug: 0.25 μg/day 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

Further study details as provided by Kumamoto University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 35
Study Start Date: January 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1.0 μg/day Alfacalcidol
Alfacalcidol 1.0 μg capsule by mouth, every day for 6 months
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
0.25 μg/day Alfacalcidol
Alfacalcidol 0.25 μg capsule by mouth, every day for 6 months
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

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Masataka Adachi, M.D., Ph.D. Department nephrology Kumamoto University
  More Information

No publications provided

Responsible Party: Masataka Adachi, Nephrology KU, Kumamoto University
ClinicalTrials.gov Identifier: NCT00828347     History of Changes
Other Study ID Numbers: KumaNeph2 
Study First Received: January 22, 2009
Results First Received: July 5, 2011
Last Updated: December 16, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplasm Metastasis
Endocrine System Diseases
Neoplasms
Neoplastic Processes
Parathyroid Diseases
Pathologic Processes
Alfacalcidol
Hydroxycholecalciferols
Maxacalcitol
Anticarcinogenic Agents
Antineoplastic Agents
Bone Density Conservation Agents
Dermatologic Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Vitamins

ClinicalTrials.gov processed this record on February 11, 2016