Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography

This study has been terminated.

(Supported by preliminary interim analysis. Not based on any safety signals in study or any quality issues that could affect efficacy of the product.)

Sponsor:

Collaborators:

ABX-CRO

Examination Management Services Inc. (EMSI)

Covance

Quintiles

Averion International Corporation

Information provided by (Responsible Party):

GE Healthcare

ClinicalTrials.gov Identifier:

NCT00209417

First received: August 24, 2005

Last updated: August 7, 2012

Last verified: August 2012

History of Changes

Purpose

It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

Condition	Intervention	Phase
Renal Insufficiency Diabetes Mellitus	Drug: Iodixanol 320-Arm 1 Drug: Iopamidol 300-Arm 2	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Diabetes

Drug Information available for: Iopamidol Iodixanol

U.S. FDA Resources

Further study details as provided by GE Healthcare:

Primary Outcome Measures:

Contrast-induced nephropathy up to day 3. The main secondary outcomes are changes in serum creatinine up to day 7 [ Time Frame: Incidence rate of CIN from Baseline-Day 3 ] [ Designated as safety issue: No ]

Enrollment:	656
Study Start Date:	June 2005
Study Completion Date:	July 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Iodixanol 320-Arm 1 Iodixanol 320 mg I/mL	Drug: Iodixanol 320-Arm 1 Other Name: Visipaque
Active Comparator: Iopamidol 300-Arm 2 Iopamidol 300 mg I/mL	Drug: Iopamidol 300-Arm 2 Other Name: Isovue

Detailed Description:

GEHC has decided not to provide this detail

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with a combination of diabetes mellitus (type I or II) and renal impairment who are referred for a contrast-enhanced CT examination.

Exclusion Criteria:

Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not permitted.
Patients undergoing dialysis or kidney transplantation will not be included.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209417

Locations

United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
United Kingdom
GE Healthcare
Amersham, United Kingdom, HP7 9LL

Sponsors and Collaborators

GE Healthcare

ABX-CRO

Examination Management Services Inc. (EMSI)

Covance

Quintiles

Averion International Corporation

Investigators

Study Director:

Judith A Johnson, MS, MBA

GE Healthcare

More Information

No publications provided

Responsible Party:	GE Healthcare
ClinicalTrials.gov Identifier:	NCT00209417 History of Changes
Other Study ID Numbers:	DXV406
Study First Received:	August 24, 2005
Last Updated:	August 7, 2012
Health Authority:	United States: Food and Drug Administration Austria: Federal Ministry for Health and Women Belgium: Ministry of Social Affairs, Public Health and the Environment France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Italy: Ministry of Health Norway: Norwegian Medicines Agency Spain: Ministry of Health and Consumption Sweden: Medical Products Agency Switzerland: Swissmedic Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) United Kingdom: Medicines and Healthcare Products Regulatory Agency Czech Republic: State Institute for Drug Control Hungary: National Institute of Pharmacy Poland: Ministry of Health

Keywords provided by GE Healthcare:

Iodixanol
Iopamidol
computed tomography
Patients with pre-existing renal impairment and diabetes

Additional relevant MeSH terms:

Diabetes Mellitus
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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