NCT01136876

Kidney Damage in Patients With Moderate Fall in eGFR

Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin as New Biomarker in Patients With Moderate Fall in eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Bracco Diagnostics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare Iopamidol injection 370 and Iodixanol 320 in evaluating Neutrophil Gelatinase-Associated Lipocalin (NGAL) in patients with moderate fall in eGFR

Detailed description

This is a pilot study having a randomized, double-blind parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have eGFR greater than or equal to 30 mL/min and less than or equal to 59 mL/min. Statistical summaries will be presented to analyze the various lab tests results for the two groups.

Conditions

• Coronary Artery Stenosis

Interventions

Type	Name	Description
DRUG	Iopamidol	Iopamidol 370, one time administration for percutaneous coronary intervention
DRUG	Iodixanol-320	Iodixanol-320 single administration for percutaneous coronary intervention procedure

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2010-06-04
• Last updated: 2020-11-04
• Results posted: 2013-12-30

Locations

4 sites across 2 countries: United States, Canada