NCT01382212View on ClinicalTrials.gov

A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

PHASE3CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
End-Stage Renal DiseaseSecondary Hyperparathyroidism
Interventions
DRUG

paricalcitol

Paricalcitol soft capsule. Starting dose of paricalcitol was determined by the intact parathyroid hormone (iPTH) value (iPTH/120) from prior to Day 1, rounded down to the nearest whole number, not to exceed 16 µg 3 times weekly, no more frequently than every other day. Decisions to hold, maintain, increase, or decrease a dose were based on the iPTH, phosphorus, and calcium results generated from the most recent visit and within target Kidney Dialysis Outcomes Quality Initiatives (KDOQI) levels.

All Listed Sponsors
lead

AbbVie (prior sponsor, Abbott)

INDUSTRY

NCT01382212 - A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis | Biotech Hunter | Biotech Hunter