Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography

Phase 4

Terminated

• Conditions: Renal Impairment
• Interventions: Drug: Ioversol 320 mgI/mL; Drug: Iodixanol 320 mgI/mL

• Registration Number: NCT00793182
• Lead Sponsor: Guerbet

Brief Summary

The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography.

Detailed Description

Contrast-induced nephropathy (CIN) is an acute decline in renal function after the administration of iodinated contrast agents. CIN is commonly defined as an increase in post contrast serum creatinine (SCr) greater than or equal to 25% or an absolute increase greater than or equal to 0.5 mg/dL from pre contrast baseline values. Study will evaluate and compare the effects of two (2) contrast media products on renal function in subjects with stable reduced renal function while undergoing contrast-enhanced computed tomography.

Study Timeline

• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-17
• Study First Posted: 2008-11-19
• Study Start: 2009-01
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2017-08-01
• Results First Submitted QC: 2017-09-04
• Results First Posted: 2017-09-29
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Males and females 18 years of age or older
• Subjects scheduled for a clinically indicated CECT requiring 40 grams of iodine (125 mL)
• Subjects have an abnormal screening SCr that results in a calculated eGFR of < 60 mL/min/1.73 m2 using the MDRD formula and acute causes for an elevation in SCr have been excluded
• Subjects have stable reduced renal function which is defined as an abnormal screening SCr measurement with a < 15% difference from the oldest historical SCr measurement obtained within the proceeding 1 week to 12 weeks
• Subjects must provide written consent and agree to abide by the site and study requirements

Exclusion Criteria

• Subjects previously entered into this study
• Subjects on dialysis
• Subjects received any investigational drug within 30 days of contrast administration or participated in an investigational study within 30 days prior to study enrollment
• Subjects have undergone a procedure using iodinated or gadolinium contrast agent within 7 days prior to contrast administration, or is scheduled to receive additional doses of contrast agents during the 48-72 hour post-study contrast administration
• Subjects in acute renal failure or have one or more known causes of acute renal failure
• Subjects have known or suspected unstable renal function
• Subjects scheduled for a surgical intervention or other procedure within 72 hours after the contrast administration
• Subjects taking NSAIDs (with the exception of ASA) and/or any type of diuretics who cannot discontinue these drugs post contrast administration and hold all subsequent doses until the 48-72 hour post contrast SCr has been drawn
• Subjects taking aminoglycosides
• Subjects known to have an organ transplantation
• Subjects have severe congestive heart failure (Class III-IV)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ioversol 320 mgI/mL	Ioversol 320 mgI/mL
2	Iodixanol 320 mgI/mL	Iodixanol 320 mgI/mL

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Contrast-induced Nephropathy (CIN)	Based on the SCr values of each patient measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration	Contrast-induced nephropathy (CIN) is defined as an increase of ≥ 25% or an increase of ≥ 0.5 mg/dL from baseline serum creatinine (SCr), within 48 - 72 hours after contrast medium administration.; For each patient, SCr values were measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration.

Trial Locations

Locations (13)

Albert Einstein Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

UAB Hospital; 🇺🇸 Birmingham, Alabama, United States

Providence Hospital; 🇺🇸 Washington, District of Columbia, United States

Methodist Medical Center of Illinois; 🇺🇸 Peoria, Illinois, United States

Trinity Clinic; 🇺🇸 Tyler, Texas, United States

Maine Research Associates; 🇺🇸 Auburn, Maine, United States

Radiology LTD; 🇺🇸 Tucson, Arizona, United States

Genesys Regional Medical Center; 🇺🇸 Grand Blanc, Michigan, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Radiology Consultants, Inc.; 🇺🇸 Youngstown, Ohio, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Wake Research Associates; 🇺🇸 Raleigh, North Carolina, United States