Kidney Damage in Patients With Moderate Fall in eGFR

Bracco

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Stenosis

Treatments: Drug: Iodixanol-320; Drug: Iopamidol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01136876

IOP-117

Details and patient eligibility

About

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

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age and provides informed consent
• Scheduled to undergo percutaneous coronary intervention
• Documented pre-dose Estimated glomerular filtration rate (eGFR) of greater than or equal to 30 mL/min/1.73 m squared and less than or equal to 59 mL/min/1.73 m squared

Exclusion criteria

• Pregnant or lactating females
• Severe congestive heart failure
• History of hyperthyroidism;
• Unstable renal function
• Emergency PCI
• History of hypersensitivity to iodinated contrast agents
• Receiving diuretics to prevent acute renal injury

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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57 participants in 2 patient groups

Iopamidol

Active Comparator group

Description:

Non-ionic low-osmolar iodinated contrast media

Treatment:

Drug: Iopamidol

Iodixanol

Active Comparator group

Description:

Non-ionic iso-osmolar iodinated contrast media comparator

Treatment:

Drug: Iodixanol-320