Overview

Efficacy and Safety of Alfacalcidol Compared to Calcitriol for Treatment of Secondary Hyperparathyroidism

Status:
Completed

Trial end date:
2009-08-01

Target enrollment:
0

Participant gender:
All

Summary

This study was performed to determine whether calcitriol provides a therapeutic advantage to alfacalcidol for treatment of secondary hyperparathyroidism in ESRD patients.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Mahidol University

Treatments:

Alfacalcidol
Calcitriol
Hydroxycholecalciferols

Criteria

Inclusion Criteria:

- Chronic hemodialysis patients who underwent scheduled hemodialysis for at least 3
months with secondary hyperparathyroidism (intact PTH levels > 300 pg/mL)

Exclusion Criteria:

- (1) age < 18 years (2) hypersensitivity to calcitriol or alfacalcidol (3) inadequate
dialysis [defined as single-pooled Kt/V (sp-Kt/V) <1.2 and <2.0 for thrice a week and
twice a week hemodialysis] (4) corrected serum calcium >10.2 mg/dL or serum phosphate
>6 mg/dL after adjusting dialysate calcium and phosphate binders (5) diameter of
parathyroid gland >10 mm (6) pregnancy or lactation (7) liver cirrhosis (8) active
kidney transplantation (9) previous parathyroidectomy (10) malignancy or chronic
infection/inflammation.