Single blind study comparing nephrotoxicity in patients with decreased renal function after intravenous gadodiamide(Omniscan) or gadopenteate (Magnevist) injection in routine clinical Magnetic Resonance Angiography (MRA)

Malmö University Hospital, Dep of Radiology0 个研究点目标入组 40 人开始时间: 2005年11月22日最近更新: 2012年3月19日

试验速览

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•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
•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.

发起方

Malmö University Hospital, Dep of Radiology