Patients with diabetes (type I or II) and impaired renal function defined as pre-study serum creatinine =150µmol/l if man and 133µmol/l if woman or an estimated prestudy glomerular filtration rate of = 50 ml/min. Patients are referred to a routine clinical magnetic resonance angiography (MRA).
Conditions
Interventions
Trade Name: Omniscan
Pharmaceutical Form: Solution for injection
INN or Proposed INN: gadodiamid
Concentration unit: mmol/ml millimole(s)/millilitre
Concentration type: equal
Concentration number: 0,5
Sponsors
Malmö University Hospital, Dep of Radiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1)The patient is a man or woman. 2)For women of childbearing potential, the results of a serum human chorionic gonadotropin pregnancy test (beta-hCG), done at screening (with the result known before investigational product administration), must be negative. Only those women who are surgically sterile (have had a documented bilateral oophorectomy and/or documented hysterectomy) or postmenopausal (cessation of menses for more than 1 year) will be allowed to enrol in the study without a pregnancy test at screening. 3)The patient is conscious and able to comply with study procedures. 4)Written, informed consent is obtained. 5)The patient has diabetes (type I or II) for at least 1 year 6)The patient has impaired renal function defined as pre-study serum creatinine =150µmol/l if a man and 133µmol/l if a woman or an estimated pre-study glomerular filtration rate of = 50 ml/min. 7)Patients are referred to a routine clinical magnetic resonance angiography (MRA). 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: Exclusion criteria 1)The patient is lactating. 2)The patient is pregnant as defined by a serum or urine beta-hCG pregnancy test obtained within the 36 hours before dosing. 3)The patient was previously included in this study. 4)The patient received CM (iodinated in radiography or MRI CM) less than 7 days before or will receive CM in the 7 days after investigational product administration. 5)Has known allergies to any of the investigational medications. 6)The patient is on concurrent administration of nephrotoxic drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and compare the effects of two different contrast media Omniscan and Magnevist, on renal function ;Secondary Objective: To evaluate and compare the safety profile of Omniscan and Magnevist To evaluate and compare the efficacy of Omniscan and Magnevist ;Primary end point(s): The primary safety endpoint will be the peak increase in serum creatinine (micromol/L) after administration of contrast media calculated as maximum increase during day 0 to day 7 Secondary endpoints Safety: -Peak increase in serum Cystatin C after administration of contrast media calculated as maximum increase during day 0 to day 7 compared to baseline. -The incidence of contrast media induced nephropathy, defined as number of patients with a peak increase in Scr of at least 44.2 µmol/L (0.5 mg/dL) from baseline to day 7 will be analysed. -The number of patients with a peak increase in Scr of at least 88.4 µmol/L (1.0 mg/dL) from baseline to day 7 will be analysed. Efficacy: - Overall image quality - Quality of diagnostic information | — |
Countries
Sweden
Outcome results
None listed