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OpenTrials
Completed

NCT Number: NCT00289614

Patients With Renal Impairment and Diabetes Undergoing Computed Tomography (CT)

The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue (iopamidol) or Visipaque in diabetic patients with moderate to severe chronic renal impairment undergoing clinically indicated contrast enhanced multidetector computed tomography (MDCT). Serum creatinine will be measured before and up to 48-72 hours post dose.

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Key information

Conditions

Kidney Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bracco Diagnostics, Inc.

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Referred for contrast enhanced MDCT
  • Documented predose eGFR of greater than or equal to 20 and less than 60 mL/min/1.73m2
  • Diagnosed as having diabetes mellitus

Exclusion criteria

  • Unstable renal function
  • Unstable diabetes
  • Concurrent administration of nephrotoxic drugs
  • Undergoing dialysis

Treatment and study plan

Iopamidol 370 mgI/dL

Drug

Primary outcomes

  1. Increase in serum creatinine (SCr) at 48-72 hours post dose

Secondary outcomes

  1. Decrease in estimated glomerular filtration rate (eGFR) at 48-72 hours post dose; occurrence of adverse events

Sponsors and collaborators

Lead sponsor

Bracco Diagnostics, Inc

Industry

Registry information

Official study title

Patients With Renal Impairment and Diabetes Undergoing Computed Tomography

Important dates

Study start
2006
Study completion
2007
First posted
Feb 10, 2006
Registry last updated
Jan 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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