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

NCT00793182 | Terminated Phase 4 Results

• 1 other identifier: 1323-07-872
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 13

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.

Conditions

Renal Impairment

Keywords

Renal; Kidney; Contrast Induced Nephropathy

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Contrast-induced Nephropathy (CIN)

  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.

  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

Study Arms (2)

1

ACTIVE COMPARATOR

Ioversol 320 mgI/mL

Drug: Ioversol 320 mgI/mL

2

ACTIVE COMPARATOR

Iodixanol 320 mgI/mL

Drug: Iodixanol 320 mgI/mL

Interventions

Ioversol 320 mgI/mL DRUG

125 mL of Ioversol administered in the vein

Also known as: Optiray

1

Iodixanol 320 mgI/mL DRUG

125 mL of Iodixanol administered in the vein

Also known as: Visipaque

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Guerbet: lead

Study Sites (13)

UAB Hospital

Birmingham, Alabama, 35233, United States

Location

Radiology LTD

Tucson, Arizona, 85711, United States

Location

Providence Hospital

Washington D.C., District of Columbia, 20017, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61602, United States

Location

Maine Research Associates

Auburn, Maine, 04210, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

University of Rochester Medical Center

Rochester, New York, 114642, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Radiology Consultants, Inc.

Youngstown, Ohio, 44512, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Trinity Clinic

Tyler, Texas, 75701, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

ioversol; iodixanol

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

Due to the small number of patients enrolled, no statistical analyses were performed.

Results Point of Contact

• Title: Corinne Dubourdieu, PharmD, Head of Clinical Projects and Medical Writing
• Organization: Guerbet

corinne.dubourdieu@guerbet-group.com

33 (0) 1 45 91 50 00

Study Officials

• Eddie Darton, MD

  Mallinckrodt

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 6, 2019
• Results First Posted: September 29, 2017

Record last verified: 2019-02

Locations

US (13)