NCT01402219

Nephrotoxicity of Iopamidol Versus Iodixanol in High-Risk Patients

Nephrotoxicity of Iopamidol Versus Iodixanol in High-Risk Patients:A Multicentre Randomized Double-Blind Trail of Contrast-Induced Nephropathy in Patients With Chronic Kidney Disease

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) in patients with chronic kidney disease undergoing coronary angiography.

Detailed description

To compare the incidence of contrast-induced nephropathy (CIN)(an absolute SCr increase 0.5 mg/dL from baseline) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) in patients with chronic kidney disease (serum creatinine level more than 1.5 mg/dL for men and more than 1.3 mg/dL for women or preprocedural estimated glomerular filtration rate(eGFR):15-60 mL/min/1.73 m2) undergoing coronary angiography.

Conditions

• Chronic Renal Disease

Interventions

Type	Name	Description
DRUG	Iopamidol injection 76%	Iopamiro-370 (Iopamidol injection 76%) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution
DRUG	iodixanol	Visipaque 320 (iodixanol) injection is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution

Timeline

• Start date: 2008-11-01
• Primary completion: 2013-02-01
• Completion: 2013-05-01
• First posted: 2011-07-26
• Last updated: 2013-08-28

Locations

1 site across 1 country: China