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

NCT00209417 | Terminated Phase 4 Results

• 1 other identifier: DXV406
• Study Type: interventional
• Target: 656
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Renal Insufficiency; Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Assessment of the Incidence Rate of Contrast Medium-Induced Nephropathy (CIN) Between Iodixanol and Iopamidol in Patients With Impaired Renal Function.

  The primary endpoint was the incidence rate of CIN, defined as an intra-individual increase in serum creatinine (SCr) of greater than or equal to 44.2 µmol/L (greater than or equal to 0.5 mg/dL). Subjects with a pre-contrast (baseline) serum creatinine value greater than or equal to 1.5 mg/dL for males and greater than or equal to 1.3 mg/dL for females or eGFR of less than or equal to 50 mL/min/1.73m squared, and a post-contrast serum creatinine value available on days 2 or 3, administered greater than or equal to100 mL or greater than or equal to 1.5 mL/kg bodyweight IMP, without presence of any major protocol violations, and without evidence of other causes inducing acute renal dysfunction.

  From baseline up to 3 days post contrast administration.

Secondary Outcomes (1)

• Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination.

  Within 2, 3 and 7 days post contrast administration.

Study Arms (2)

Iodixanol 320-Arm 1

ACTIVE COMPARATOR

Iodixanol 320 mg I/mL

Drug: Iodixanol 320-Arm 1

Iopamidol 300-Arm 2

ACTIVE COMPARATOR

Iopamidol 300 mg I/mL

Drug: Iopamidol 300-Arm 2

Interventions

Iodixanol 320-Arm 1 DRUG

Also known as: Visipaque

Iodixanol 320-Arm 1

Iopamidol 300-Arm 2 DRUG

Also known as: Isovue

Iopamidol 300-Arm 2

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• GE Healthcare: lead
• ABX CRO: collaborator
• Examination Management Services Inc.: collaborator
• Covance: collaborator
• Quintiles, Inc.: collaborator
• Averion International Corporation: collaborator

Study Sites (2)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

GE Healthcare

Amersham, HP7 9LL, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency; Diabetes Mellitus

Interventions

iodixanol; Iopamidol

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Paul Gordon, PhD
• Organization: GE Healthcare

Paul.Gordon@ge.com

011-47-2318-5822

Study Officials

• Judith A Johnson, MS, MBA

  GE Healthcare

  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: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2005
• First Posted: September 21, 2005
• Study Start: June 1, 2005
• Primary Completion: May 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 17, 2014
• Results First Posted: October 10, 2014

Record last verified: 2014-10

Locations

GB (1); US (1)