Effectiveness of Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients.

Phramongkutklao College of Medicine and Hospital502 enrolled

Overview

Primary objective was to evaluate the efficacy between daily and pulse oral alfacalcidol treatment of SHPT in chronic hemodialysis patients, a 12-week treatment. Secondary objective was to observe the adverse effects between these two treatment regimens.

ESRD patients with secondary hyperparathyroidism in 3 hemodialysis centers were enrolled. They were assigned to either oral daily or pulse (trice a week) alfacalcidol treatments using block-of-4 randomization. Alfacalcidol in both groups were equal at the dose of 6 microgram per week. Clinical and laboratory data were obtained at baseline and were monitored every 4 weeks for 12 weeks. Primary outcome was the difference of the mean PTH reduction between two groups at the end of the study by unpaired-T test. All possible adverse events were carefully monitored.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

502

Conditions

Alfacalcidol, Secondary Hyperparathyroidism, Hemodialysis

Interventions

AlfacalcidolDRUG

Alfacalcidol 1 microgram/capsule

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 y ESRD on HD KT/V ≥ 3.6/wk 2˚HPT Stable in P binder for 4 wk Exclusion Criteria: * Alfacalcidol allergy Serum Ca ≥ 10.5 mg/dL Serum P ≥ 5.5 mg/dL Pregnancy On phenytoin, phenobarbital

Outcomes

Primary Outcomes

Primary outcome was the difference of the mean PTH reduction between two groups at the end of the study by unpaired-T test.

mean PTH reduction between two groups at the end of the study by unpaired-T test.

Time frame: 12 week

Data from ClinicalTrials.gov

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