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Kidney Damage in Patients With Moderate Fall in eGFR

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ClinicalTrials.gov Identifier: NCT01136876
Recruitment Status : Completed
First Posted : June 4, 2010
Results First Posted : December 30, 2013
Last Update Posted : December 30, 2013
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

June 2, 2010
June 4, 2010
September 17, 2013
December 30, 2013
December 30, 2013
November 2010
November 2012   (Final data collection date for primary outcome measure)
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media [ Time Frame: Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose ]
Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media.
Impact on the trajectory of serum and urinary NGAL following the administration of non-ionic kiw osmolar contrast media in comparison to a non-ionic, iso-osmolar contrast media [ Time Frame: 2 to 72 hours ]
Complete list of historical versions of study NCT01136876 on ClinicalTrials.gov Archive Site
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Kidney Damage in Patients With Moderate Fall in eGFR
A Phase IV Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a New Bio-Marker in Patients With Moderate Fall in eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320
This is a pilot study having a randomized, double-blind parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have eGFR greater than or equal to 30 mL/min and less than or equal to 59 mL/min. Statistical summaries will be presented to analyze the various lab tests results for the two groups.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Coronary Artery Stenosis
  • Drug: Iopamidol
    Iopamidol 370, one time administration for percutaneous coronary intervention
    Other Name: Isovue-370
  • Drug: Iodixanol-320
    Iodixanol-320 single administration for percutaneous coronary intervention procedure
    Other Name: Visipaque 320
  • Active Comparator: Non-ionic iodinated contrast agent
    Intervention: Drug: Iopamidol
  • Active Comparator: Non-ionic contrast media comparator
    Intervention: Drug: Iodixanol-320
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
48
November 2012
November 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 18 years of age and provides informed consent
  • Scheduled to undergo percutaneous coronary intervention
  • Documented pre-dose Estimated glomerular filtration rate (eGFR) of greater than or equal to 30 mL/min/1.73 m squared and less than or equal to 59 mL/min/1.73 m squared

Exclusion Criteria:

  • Pregnant or lactating females
  • Severe congestive heart failure
  • History of hyperthyroidism;
  • Unstable renal function
  • Emergency PCI
  • History of hypersensitivity to iodinated contrast agents
  • Receiving diuretics to prevent acute renal injury
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01136876
IOP-117
No
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Bracco Diagnostics, Inc
Bracco Diagnostics, Inc
Not Provided
Study Director: Maria Luigia Storto, MD Bracco Diagnostics, Inc
Bracco Diagnostics, Inc
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP