Phase 4 N=57 Randomized Triple-blind Diagnostic

Kidney Damage in Patients With Moderate Fall in eGFR

Coronary Artery Stenosis

Bottom Line

View on ClinicalTrials.gov: NCT01136876 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2013

Primary outcome: Primary: Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration — -27.76; -11.11; -11.84; -8.23 ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Iopamidol (Drug); Iodixanol-320 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bracco Diagnostics, Inc
Primary completion: Nov 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration	-27.76; -11.11; -11.84; -8.23; -27.06; -10.68	—

Summary

To compare Iopamidol injection 370 and Iodixanol 320 in evaluating Neutrophil Gelatinase-Associated Lipocalin (NGAL) in patients with moderate fall in eGFR

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01136876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.