A Multicentre, Phase 3, Open-Label, Controlled Study Evaluating the Efficacy andSafety of 0.1 mmol/kg Omniscan (Gadodiamide Injection) in Magnetic ResonanceAngiography (MRA) of the Renal Arteries
- Conditions
- Renal artery stenosis (RAS) is implicated as the underlying cause in 1% to 5% of patients with hypertension and 5% to 15% of patients with end-stage renal disease entering dialysis programs each year. Several endovascular procedures are now available for treatment. The introduction of such procedures has considerably increased the need not only for accurate detection but also for precise anatomic mapping of the extent and severity of an existing lesion.
- Registration Number
- EUCTR2004-000953-46-LT
- Lead Sponsor
- Amersham plc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 270
(1) The subject has a suspicion of or known renal artery stenosis.
(2) The subject has been referred to IA-DSA.
(3) The subject has had no intervention or a change in symptoms between 3D CE-MRA and IA-DSA.
(4) The subject is 18 years or older.
(5) The subject is conscious and able to comply with study procedures.
(6) Written and dated (i.e. date and time) informed consent is obtained.
(7) For women of childbearing potential, the results of a serum or urine human chorionic gonadotropin
(â-HCG) pregnancy test, 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 menstruation for >1 year) will be allowed to enrol in the study without a pregnancy test at
screening.
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
(1) The subject has a known hypersensitivity to either conventional X-ray or gadolinium-based MR
contrast media including, but not restricted to, the investigational product.
(2) The subject is lactating.
(3) The subject is pregnant as defined by a serum or urine â-HCG pregnancy test obtained within 24 hours
before investigational product administration.
(4) The subject has received or is scheduled to receive MRI contrast medium within 24 h prior to or less
than 24 hours after the investigational product administration.
(5) The subject has received or is scheduled to receive X-ray contrast medium within less than 24 hours
prior to or less than 24 hours after administration of investigational product.
(6) The subject has received an investigational product within 30 days prior to or will receive an
investigational product less than 24 hours after investigational product administration.
(7) The subject has an active, serious, life-threatening disease with a life expectancy of less than 6 months.
(8) The subject has had a percutaneous transluminal angioplasty (PTA) in the renal region performed
within 4 weeks prior to investigational product administration.
(9) The subject has a stent in the renal arteries.
(10) The subject has had a kidney transplantation.
(11) The subject has a serum creatinine value of >3.5 mg/dL (309.4 µmol/L).
(12) The subject has previously been included in this study.
(13) The subject has a contra-indication for MRI according to accepted clinical guidelines.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method