13
Participants
Start Date
January 31, 2009
Primary Completion Date
June 30, 2009
Study Completion Date
June 30, 2009
Calcitriol
Initial doses determined according to the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) guideline (Am J Kidney Dis 2003;42(4)Suppl 3:S1-S201). During therapy, calcitriol dose may be modified by 0.5 - 1 mcg at 2- to 4-week intervals.
Paricalcitol
Dose calculated by 0.04 to 0.1 microgram per kilogram (mcg/kg). Paricalcitol will be administered intravenously after the participants' dialysis. The paricalcitol dose will be titrated every 2 weeks until iPTH presents a reduction or up to 4 months, after which it will be adjusted monthly based on serum PTH, calcium, phosphorus and albumin measurements. Dosing may be modified by 2-4 mcg increments at 2- to 4-week intervals.
Site Reference ID/Investigator# 7118, São Paulo
Site Reference ID/Investigator# 7114, São Paulo
Lead Sponsor
Statistika Consultoria Ltda
INDUSTRY
Abbott
INDUSTRY