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.

GE Healthcare Limited and its Affiliates0 个研究点目标入组 600 人开始时间: 2009年10月13日最近更新: 2016年8月8日

适应症

试验速览

暂无简介。

•(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.

发起方

GE Healthcare Limited and its Affiliates