Kidney Damage in Patients With Moderate Fall in eGFR

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01136876
First received: June 2, 2010
Last updated: November 11, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Coronary Artery Stenosis
Drug: Iopamidol
Drug: Iodixanol-320
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 57
Study Start Date: November 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Non-ionic iodinated contrast agent Drug: Iopamidol
Iopamidol 370, one time administration for percutaneous coronary intervention
Other Name: Isovue-370
Active Comparator: Non-ionic contrast media comparator Drug: Iodixanol-320
Iodixanol-320 single administration for percutaneous coronary intervention procedure
Other Name: Visipaque 320

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136876

Locations
United States, Illinois
Springfield, Illinois, United States
Priarie Cardiovascular Consultants
Springfield, Illinois, United States
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Maria Luigia Storto, MD Bracco Diagnostics, Inc
  More Information

No publications provided

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01136876     History of Changes
Other Study ID Numbers: IOP-117
Study First Received: June 2, 2010
Results First Received: September 17, 2013
Last Updated: November 11, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Iopamidol
Iodixanol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014