NCT00537979

Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis

Prospective, Non-randomized, Multicenter Study to Assess the Efficacy and Safety of Oral or Intravenous Paricalcitol Administered Over 6 Months to Patients With Secondary Hyperparathyroidism on Dialysis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, non-randomized, multi-center study to assess the efficacy and safety of paricalcitol injection or oral administered over 6 months to patients with secondary hyperparathyroidism on dialysis.

Conditions

• Secondary Hyperparathyroidism
• Dialysis

Interventions

Type	Name	Description
DRUG	Paricalcitol injection	Most recent iPTH level in pg/mL divided by 100 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly
DRUG	Paricalcitol capsules	Most recent iPTH level in pg/mL divided by 80 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2007-10-02
• Last updated: 2011-10-25
• Results posted: 2011-10-25

Locations

12 sites across 1 country: Mexico