patients that are scheduled to undergo PCI with normal kidney function. MedDRA version: 9.1 Level: SOC Classification code 10007541 MedDRA version: 9.1 Level: SOC Classification code 10047065
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Iopamidol
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 370-
Pharmaceutical Form: Solution for
Sponsors
BRACCO IMAGING
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Enroll a patient in this study if the patient meets the following inclusion criteria: ? Provides written Informed Consent and is willing to comply with protocol requirements; ? Is at least 18 years of age; ? Is scheduled to undergo a percutaneous coronary intervention. ? Has documented estimated glomerular filtration rate [eGFR] =90 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior to enrollment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclude a patient from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed: ? Is a pregnant or lactating female. Exclude the possibility of pregnancy: ? by testing on site at the institution (serum or urine ßHCG) within 24 hours prior to the start of investigational product administration, ? by surgical history (e.g., tubal ligation or hysterectomy), ? post menopausal with a minimum 1 year without menses; ? Has any known allergy to one or more of the ingredients of the investigational products; ? Has a history of severe congestive heart failure [class IV in accordance with the classification of the New York Heart Association (NYHA)] (see Appendix A); ? Has a history of hyperthyroidism; ? Has unstable renal function (i.e., acute worsening of renal function, as determined by the Investigator, that has been observed in the seven (7) days prior to enrollment), and/or is in acute renal failure; ? Has to undergo to a percutaneous coronary intervention in an emergency situation; ? Is scheduled to receive iodinated contrast agent medium intravascularly within 48 hours post intervention; ? Has undergone a procedure with iodinated contrast medium administered intravascularly within 72 hours prior to enrollment in this trial; ? Is receiving COX-2 inhibitors, NSAIDS (with the exception of low dose aspirin = 325 mg/day), aminoglycosides, or any other drugs that carry a significant risk of nephrotoxicity during the time period beginning within 72 hours prior to contrast administration and up to 72 hours post-dose; ? Is on ACE inhibitors at the time of the procedure. They have to be stopped 24 hours before the hydration and withheld at least for 24 hours post procedure. ? Is planned to receive an intravenous diuretic or mannitol as prophylaxis to prevent acute renal injury; ? Is on metformin at the time of the procedure. Metformin must be discontinued and stopped 48 hours prior to IP administration, withheld for at least 48 hours post-dose; Clinical Trial Protocol IOP-116 Final 22-Apr-2010 Kidney Damage in Patients with Normal eGFR Iopamidol Injection Document ID: BDI-PTR-AC9855.09-IOP116PR-B001964-2.0 Confidential Page 12 ? Prior to or during the procedure, is receiving or will be receiving a prophylactic medication for renal function [e.g., N-acetylcysteine (NAC), theophylline, fenoldopam]; ? During the procedure, is known to be going to receive provocative pharmacological agents such as adenosine or dipyridamole; ? Was previously entered into this study or received an investigational compound within 30 days before admission into this study; ? Has a history of hypersensitivity to iodinated contrast agents; ? Is hemodynamically unstable within 24 hours pre-investigational product administration defined as a systolic blood pressure < 90 mmHg or requires pressor or intra-aortic balloon support; ? Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations. ? Is determined by the Investigator that the patient is clinically unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the impact on the trajectory of serum and urinary NGAL following the administration of non-ionic low osmolar contrast media (IOPAMIDOL injection 370) in comparison to a non-ionic, iso-osmolar contrast media (IODIXANOL 320) in patients with estimated glomerular filtration [eGFR] = 90 mL/min/1.73 m2 undergoing percutaneous coronary intervention (PCI).;Secondary Objective: To assess serum and urinary NGAL in relation to serum creatinine, estimated glomerular filtration rate and Cystatin C. ? To evaluate the incidence of contrast-induced-nephropathy (CIN) following the administration of IOPAMIDOL injection 370 and IODIXANOL 320 in patients with normal eGFR.;Primary end point(s): Both serum and urine NGAL data will be summarized and presented for all patients dosed. Summary statistics including mean, standard deviation, median, minimum, and maximum by time point for each investigational product will be presented in the table, as well as in the descriptive graphics for both postdose evaluation and change from the baseline. | — |
Countries
Italy
Outcome results
None listed