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

Last updated: May 1, 2010
Sponsor: Mahidol University
Overall Status: Completed

Phase

4

Condition

Hyperparathyroidism

Parathyroid Disease

Parathyroid Disorders

Treatment

N/A

Clinical Study ID

NCT01115543
358/2551
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • (1) age < 18 years (2) hypersensitivity to calcitriol or alfacalcidol (3) inadequatedialysis [defined as single-pooled Kt/V (sp-Kt/V) <1.2 and <2.0 for thrice a week andtwice 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 ofparathyroid gland >10 mm (6) pregnancy or lactation (7) liver cirrhosis (8) activekidney transplantation (9) previous parathyroidectomy (10) malignancy or chronicinfection/inflammation.

Study Design

Total Participants: 32
Study Start date:
August 01, 2008
Estimated Completion Date:
August 31, 2009

Study Description

Secondary hyperparathyroidism has a significant impact on morbidity and mortality in advanced chronic kidney disease (CKD).Both nonselective and selective vitamin D receptor activators (VDRAs) are demonstrated in many studies for their efficacy on suppression of PTH. Most of them are quite expensive and unavailable in many countries. Calcitriol and alfacalcidol are less expensive and worldwidely distributed. There is only one short-term study which directly compares these two drugs. This study demonstrates that calcitriol is superior to alfacalcidol. However, alfacalcidol is a prohormone of calcitriol. It has to be converted by 25-hydroxylase at the liver to generate 1,25-dihydroxyvitamin D3 to act on target cells. Many pharmacokinetics studies demonstrate that alfacalcidol has lower AUC compared to calcitriol if they are administered in the same dose. Therefore, the authors hypothesize that alfacalcidol may be equivalently efficacious as calcitriol if its dose is adjusted according to the pharmacokinetics studies.

Connect with a study center

  • Siriraj Medical School

    Bangkok-noi, Bangkok 10700
    Thailand

    Site Not Available

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