A post-marketing safety study in patients with moderate renal insufficiency who receive Omniscan (Gadodiamide Injection) for contrast enhanced magnetic resonance imaging (MRI)Estudio de seguridad poscomercialización en pacientes con insuficiencia renal moderada a los que se les administra OMNISCAN (inyección de gadodiamida) para la adquisición de imágenes de RM (IRM) realzada con contraste.
- Conditions
- Patients with moderate renal insufficiency (estimated eGFR > 30 and <60 mL/min/1.73m2).Pacientes con insuficiencia renal moderada (tasa de filtración glomerular [TFG] >estimada 30 y <60 ml/min/1,73 m2).MedDRA version: 9.1Level: LLTClassification code 10064499Term: Nephrogenic fibrosing dermopathy
- Registration Number
- EUCTR2009-011236-35-ES
- Lead Sponsor
- GE Healthcare Limited and its Affiliates
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
(1) The subject is 18 years of age or older at time of study entry.
(2) The subject is physically able and willing to comply with study procedures and a signed and dated informed consent is obtained.
(3) The subject has been referred for a clinically indicated MRI examination with a gadolinium-based contrast agent (GBCA).
(4) The subject has known or suspected chronic kidney disease with an eGFR >30 and <60 mL/min/1.73m2 as measured within 30 days prior to the planned index OMNISCAN administration.
(5) The subject agrees to be contacted for follow-up for 24 months.
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) Patients with known or suspected NSF based on biopsy confirmation or the onset of signs and symptoms of NSF lasting at least 7 days as follows: (a) skin - swelling, hardening and tightening; reddened or darkened patches; burning or itching ; (b) eyes - yellow raised spots on whites of eyes; or (c) bones and muscle - stiffness in joints; difficulty in moving or straightening of arms,
hands, legs or feet; bone pain especially in hips and ribs or muscle weakness.
(2) Patients allergic to any GBCA.
(3) Patients with chronic renal disease with a GFR <30 mL/min/1.73m2 as measured within 30 days prior to the planned index OMNISCAN administration.
(4) Patients with acute renal insufficiency of any severity due to the hepato-renal syndrome
or in the peri-operative liver transplantation period.
(5) Patients that were exposed to any GBCA within a period of 12 months prior the planned index administration of OMNISCAN.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To capture post-marketing safety information on patients with moderate renal insufficiency (eGFR >30 and <60 mL/min/1.73m2) undergoing routine contrast-enhanced MRI with OMNISCAN in order to assess the risk of developing nephrogenic systemic fibrosis (NSF).;Secondary Objective: Not applicable.;Primary end point(s): The primary endpoint will be the development of NSF, whether or not confirmed histologically.
- Secondary Outcome Measures
Name Time Method