Kidney Damage in Patients With Moderate Fall in eGFR

Phase 4

Completed

• Conditions: Coronary Artery Stenosis
• Interventions: Drug: Iodixanol-320; Drug: Iopamidol

• Registration Number: NCT01136876
• Lead Sponsor: Bracco Diagnostics, Inc

Brief 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.

Study Timeline

• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-03
• Study First Posted: 2010-06-04
• Study Start: 2010-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-09
• Results First Submitted: 2013-09-17
• Results First Submitted QC: 2013-11-11
• Results First Posted: 2013-12-30
• Last Update Submitted: 2020-10-14
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iodixanol	Iodixanol-320	Non-ionic iso-osmolar iodinated contrast media comparator
Iopamidol	Iopamidol	Non-ionic low-osmolar iodinated contrast media

Primary Outcome Measures

Name	Time	Method
Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration	Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose	Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media.

Trial Locations

Locations (4)

UMDNJ - RWJ Medical School; 🇺🇸 New Brunswick, New Jersey, United States

Montreal Heart Institute; 🇨🇦 Montréal, Quebec, Canada

The Institute for Clinical Research at Holy Name Medical Center; 🇺🇸 Teaneck, New Jersey, United States

Research Cooperative, St. John's Hospital; 🇺🇸 Springfield, Illinois, United States