Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects

PHASE4TerminatedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

June 30, 2009

Study Completion Date

June 30, 2009

Conditions
Secondary HyperparathyroidismDialysis
Interventions
DRUG

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.

DRUG

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.

Trial Locations (2)

04039-001

Site Reference ID/Investigator# 7118, São Paulo

05403-000

Site Reference ID/Investigator# 7114, São Paulo

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Statistika Consultoria Ltda

INDUSTRY

lead

Abbott

INDUSTRY