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

Diabetes Mellitus Clinical Trial

Official title:

GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00209417
• Other study ID #: DXV406
• Status: Terminated
• Phase: Phase 4
• First received: August 24, 2005
• Last updated: October 9, 2014
• Start date: June 2005
• Est. completion date: July 2011

Study information

• Verified date: October 2014
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustria: Federal Ministry for Health and WomenBelgium: Ministry of Social Affairs, Public Health and the EnvironmentFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: Ministry of HealthNorway: Norwegian Medicines AgencySpain: Ministry of Health and ConsumptionSweden: Medical Products AgencySwitzerland: SwissmedicNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)United Kingdom: Medicines and Healthcare Products Regulatory AgencyCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyPoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

GEHC has decided not to provide this detail

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 656
• Est. completion date: July 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus
• Renal Insufficiency

Intervention

Drug:
• Iodixanol 320-Arm 1

• Iopamidol 300-Arm 2

Locations

Country	Name	City	State
United Kingdom	GE Healthcare	Amersham
United States	GE Healthcare	Princeton	New Jersey

Sponsors (6)

Lead Sponsor	Collaborator
GE Healthcare	ABX-CRO, Averion International Corporation, Covance, Examination Management Services Inc., Quintiles, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Assessment of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-enhanced Multi-detector-row Helical Computed Tomography (MDCT) Examination.	Overall Image Quality rated as "Excellent, Good, Sufficient or Insufficient Poor" by radiologists blinded to the contrast administration.	Within 2, 3 and 7 days post contrast administration.	No