Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease

Vascular Calcification Clinical Trial

Official title:

Randomized Control Trial of Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01364688
• Other study ID #: 25-05-2011
• Status: Recruiting
• Phase: Phase 2
• First received: May 26, 2011
• Last updated: May 31, 2011
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2011
• Source: Ramathibodi Hospital
• Contact: Sinee Disthabanchong, MD
• Phone: +6622011116
• Email: tesdb[@]mahidol.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Mahidol University
• Study type: Interventional

Clinical Trial Summary

Active vitamin D at therapeutic dose may prevent vascular calcification but in supraphysiologic dose may precipitate it.

Description:

Active vitamin D compound is used frequently in the treatment of hyperparathyroidism in chronic kidney disease. Recent evidence from animal studies suggested that low dose of active vitamin D may be protective against vascular calcification, whereas high dose could precipitate it. The present study will examine the effect of low dose oral alfacalcidol on coronary artery calcification in predialysis chronic kidney disease patients with hyperparathyroidism.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Predialysis chronic kidney disease with GFR < 90 mL/min/1.73m2

• PTH above the upper limit of normal

• serum calcium and phosphate below the upper limit of normal

Exclusion Criteria:

• changes in GFR>15% during the past 3 months

• receive elemental calcium>500 mg/day

• currently taking active vitamin D, oral calcium with elemental calcium>500 mg/day or bisphosphonate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Calcinosis
• Coronary Artery Disease
• Kidney Diseases
• Renal Insufficiency, Chronic
• Vascular Calcification

Intervention

Drug:
• oral alfacalcidol
Oral alfacalcidol 0.5 microgram per day
• no drug
no drug

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Ramathibodi Hospital, Mahidol University	Phayathai	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Coronary Artery Calcification		6 months and 12 months	No