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)

• Conditions: 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).

• Registration Number: EUCTR2005-004207-11-SE
• Lead Sponsor: Malmö University Hospital, Dep of Radiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified