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

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

ABX CRO, Examination Management Services Inc., Covance, Quintiles, Inc., Averion International Corporation

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.

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.

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.

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.