Last updated: May 1, 2010
Sponsor: Mahidol University
Overall Status: Completed
Phase
4
Condition
Hyperparathyroidism
Parathyroid Disease
Parathyroid Disorders
Treatment
N/AClinical Study ID
NCT01115543
358/2551
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Siriraj Medical School
Bangkok-noi, Bangkok 10700
ThailandSite Not Available
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