Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)

NCT ID: NCT00828347

Last Updated: 2016-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-07-31

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.

Conditions

Secondary Hyperparathyroidism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1.0 μg/day Alfacalcidol

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

Group Type: OTHER

1.0 μg/day Alfacalcidol

Intervention Type: DRUG

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.

0.25 μg/day Alfacalcidol

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

Group Type: OTHER

0.25 μg/day Alfacalcidol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

One alpha; One alpha

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kumamoto University

OTHER

Sponsor Role: lead

Responsible Party

Masataka Adachi

Nephrology KU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Masataka Adachi, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department nephrology Kumamoto University

Locations

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Countries

Japan

Other Identifiers

KumaNeph2

Identifier Type: -

Identifier Source: org_study_id