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

Phramongkutklao College of Medicine and Hospital

Status: Completed

Conditions: Alfacalcidol, Secondary Hyperparathyroidism, Hemodialysis

Treatments: Drug: Alfacalcidol

Study type: Interventional

Funder types: Other

Identifiers

NCT02895061

PMK-0007

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 502 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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502 participants in 2 patient groups

A: Daily

Experimental group

Description:

A: oral daily alfacalcidol treatments total 6 microgram/week

Treatment:

Drug: Alfacalcidol

B: Pulse

Experimental group

Description:

B: pulse (trice a week) alfacalcidol treatments total 6 microgram/week

Treatment:

Drug: Alfacalcidol