NCT00616902

The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5

Clinical Study Protocol M10-221 The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effects of paricalcitol injection on cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have left ventricular hypertrophy (LVH).

Conditions

• Chronic Kidney Disease (CKD) Stage 5
• Hypertrophy, Left Ventricular

Interventions

Type	Name	Description
DRUG	paricalcitol injection 4 mcg/mL	Paricalcitol Injection 4 mcg/mL intravenously three times a week during dialysis
DRUG	Placebo Injection 4 mcg/mL	Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-02-15
• Last updated: 2012-01-20
• Results posted: 2010-08-04

Locations

76 sites across 13 countries: United States, Australia, Czechia, Germany, Greece, Italy, Poland, Puerto Rico, Romania, Russia, Spain, Taiwan, United Kingdom