Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography (CINOPSIS CT)
This study has been terminated.
(Slow enrollment)
Sponsor:
Mallinckrodt
Information provided by:
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT00793182
First received: November 17, 2008
Last updated: June 16, 2009
Last verified: June 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Impairment |
Drug: Ioversol 320 mgI/mL Drug: Iodixanol 320 mgI/mL |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) |
| Official Title: | A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Optiray 320 mgI/mL and Visipaque 320 mgI/mL on Renal Function in Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography |
Resource links provided by NLM:
Further study details as provided by Mallinckrodt:
Primary Outcome Measures:
- Evaluate the incidence of contrast-induced nephropathy (CIN), 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 administration. [ Time Frame: Labs obtained 2-24 hours before and 48-72 hours after contrast administration, with a 7-day follow-up if indicated ] [ Designated as safety issue: Yes ]
| Enrollment: | 10 |
| Study Start Date: | January 2009 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Ioversol 320 mgI/mL
|
Drug: Ioversol 320 mgI/mL
125 mL of Ioversol administered in the vein
Other Name: Optiray
|
|
Active Comparator: 2
Iodixanol 320 mgI/mL
|
Drug: Iodixanol 320 mgI/mL
125 mL of Iodixanol administered in the vein
Other Name: Visipaque
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793182
Locations
| United States, Alabama | |
| UAB Hospital | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Arizona | |
| Radiology LTD | |
| Tucson, Arizona, United States, 85711 | |
| United States, District of Columbia | |
| Providence Hospital | |
| Washington, District of Columbia, United States, 20017 | |
| United States, Illinois | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61602 | |
| United States, Maine | |
| Maine Research Associates | |
| Auburn, Maine, United States, 04210 | |
| United States, Michigan | |
| Genesys Regional Medical Center | |
| Grand Blanc, Michigan, United States, 48439 | |
| United States, New York | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 114642 | |
| United States, North Carolina | |
| Wake Research Associates | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Ohio | |
| Radiology Consultants, Inc. | |
| Youngstown, Ohio, United States, 44512 | |
| United States, Pennsylvania | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822 | |
| Albert Einstein Medical Center | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| Temple University Hospital | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, Texas | |
| Trinity Clinic | |
| Tyler, Texas, United States, 75701 | |
Sponsors and Collaborators
Mallinckrodt
Investigators
| Study Director: | Eddie Darton, MD | Mallinckrodt |
More Information
No publications provided
| Responsible Party: | Eddie Darton, Jr., MD, Mallinckrodt |
| ClinicalTrials.gov Identifier: | NCT00793182 History of Changes |
| Other Study ID Numbers: | 1323-07-872 |
| Study First Received: | November 17, 2008 |
| Last Updated: | June 16, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mallinckrodt:
|
Renal Kidney Contrast Induced Nephropathy |
Additional relevant MeSH terms:
|
Renal Insufficiency Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013