Subjects with a combination of diabetes mellitus (type I or II), and impaired renal function. MedDRA version: 7.0 Level: Pt Classification code 10061835
Conditions
Interventions
Trade Name: Visipaque 320 mgI/ml
Product Name: Visipaque 320 mg I/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Iodixanol
Concentration unit: mg/ml milligram(s)/millilitre
Conce
Sponsors
Amersham Health S.A. (parte de GE Healthcare Ltd y sus filiales)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.) The subject is at least 18 years old. 2.) The subject has diabetes mellitus (type I or II), treated with insulin or oral antidiabetic agents for at least 1 year. 3.) The subject has a pre-study serum creatinine = 1.7 mg/dl (150 µmol/l) if a man, or = 1.5 mg/dl (133 µmol/l) if a woman, or an estimated pre-study glomerular filtration rate (eGFR) = 50 mL/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) equation.* The pre-study serum creatinine value must not be older than 3 months and any acute causes of impaired renal function have to be ruled out. * the four-component MDRD equation provides estimates of GFR standardised for body surface, based on the variables serum creatinine concentration (SCr), age, race, and sex: eGFR (mL/min/1.73m2) = 186 x SCr-1.154 x age-0.203 (x 0.742 if female) (x 1.210 if black) Pre-study serum creatinine has to be expressed in milligrams per decilitre, age in years. 4.) The subject is referred for a contrast-enhanced MDCT examination, using a standardised CM volume of 1.5 mL per kilogram of body weight and an injection rate of 4 mL/s (in cases with inadequate venous access, a flow of 3 mL/s may be applied). For subjects with a body weight exceeding 100 kilogram, a total CM volume of 150 mL should be administered. 5.) The subject is a man, or a woman who is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (with cessation of menses for more than 1 year), or, if of child-bearing potential, the result of a urine or serum ?-HCG pregnancy test conducted at screening must be known to be negative before IMP administration. 6.) The subject is able and willing to comply with study procedures. 7.) Signed and dated (i.e., date and time) written informed consent is obtained. 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: 1.) The subject is pregnant or lactating. 2.) The subject was previously included in this study. 3.) The subject has received another IMP within 30 days before or is scheduled to receive one within 7 days after IMP administration. 4.) The subject has received iodinated contrast medium within 7 days before or will receive one within 7 days after IMP administration. 5.) The subject has a history of serious hypersensitivity reaction to iodinated contrast media. 6.) The subject has non-compensated heart failure (NYHA III or IV). 7.) The subject has manifest thyrotoxicosis. 8.) The subject is in acute renal failure or in acute on chronic renal failure. 9.) The subject has undergone kidney transplantation. 10.) The subject is on haemodialysis or peritoneal dialysis. 11.) The subject has liver cirrhosis with ascites. 12.) The subject has multiple myeloma. 13.) The subject is haemodynamically unstable pre-study. 14.) The subject is scheduled for major surgery within 7 days after IMP administration. 15.) The subject has received or will receive any of the following potentially nephroprotective drugs from 3 days before until 7 days after IMP administration: n-acetylcysteine, fenoldopam, dopamine, or hydration with sodium bicarbonate. Concurrent medication with other drugs that are potentially nephroprotective, like calcium channel blockers or theophylline, are permitted provided they are used for the subject’s underlying disease (e.g., cardiac disease, arterial hypertension, bronchial asthma). 16.) The subject has received nephrotoxic drugs within 7 days before or will receive such drugs within 7 days after IMP administration. Respective nephrotoxic drugs include antibiotics (e.g., aminoglycosides, vancomycin, amphotericin B), antineoplastic agents (e.g., methotrexate, cisplatin), and immunosuppressants (e.g., cyclosporine). 17.) The subject has received nonsteroidal anti-inflammatory drugs (NSAID) within 3 days before or will receive such drugs within 7 days after IMP administration, with the exception of low dose aspirin (up to 325 mg per day). However, subjects who are on a stable NSAID regimen may be enrolled. 18.) The subject has had or is planned to have the initiation, discontinuation, or change in dose of any of the following from 3 days before until 7 days after IMP administration: trimethoprim, cimetidine, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers. 19.) The subject is on metformin treatment at the time of the study procedure: metformin administration has to be discontinued prior to IMP administration, according to local guidelines, withheld for at least 48 hours, and resumed only if renal function / serum creatinine did not worsen compared to the baseline values.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and compare the effects of two different contrast media, iodixanol 320 mg I/mL and iopamidol 300 mg I/mL, on renal function;Secondary Objective: To evaluate and compare the safety profile of iodixanol 320 mg I/mL and iopamidol 300 mg I/mL To evaluate and compare the efficacy of iodixanol 320 mg I/mL and iopamidol 300 mg I/mL ;Primary end point(s): The primary endpoint will be the incidence rate of contrast-induced nephropathy (CIN), defined as an intra-individual increase in serum creatinine of at least 44.2 µmol/l (0.5 mg/dl) from baseline up to day 3. | — |
Countries
Italy, Spain
Outcome results
None listed