A Post-Marketing Safety Study in patients with Moderate Renal Insufficiency who receive Omniscan (gadodiamideinjection) for Contrast-Enhanced Magnetic ResonanceImaging (MRI) of Protocol no.: GE-041-075
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- To capture post-marketing safety information in patients with moderate renal insufficiency undergoing routine contrast-enhanced MRI with administration of OMNISCAN in order to assess the risk for developing nephrogenic systemic fibrosis. [ Time Frame: Time zero equals the date of Omniscan injection. All subjects will be followed for approximately 2 years after the administration of Omniscan ] [ Designated as safety issue: Yes ]
研究概览
简要总结
This will be a Global study which is conducted in upto 100 centres worldwide. The study is designed to collect safety data that assesses the occurrence of NSF among patients with moderate renal insufficiency who are administered Omniscan (gadodiamide) injection, during a MRI with a 2 year follow-up period. Target enrollment is approximately 600 patients globally. The patient recruitment started 10 June 2009 and is expected to be completed by late 2010.Omniscan will be administered intravenously in 100 patients in India as per the approval from DCGI, at the medical discretion of the prescribing physician. Date of enrollment for Indian patient will be somewhere in 30 January 2010.
研究设计
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
入选标准
- •The subject has been referred for a clinically indicated MRI examination with a gadolinium-based contrast agent.
- •The subject is > 18 years of age at time of study entry.The subject has known or suspected chronic kidney disease with an eGFR greater than or equal to 30mL and <60 mL/min/1.73 m2 as measured within 30 days prior to the planned index OMNISCAN administration(GFR will beestimated all subjects using the MDRD GFR extended version calculator).
- •The subject agrees to be contacted for follow-up for 24 months.
排除标准
- •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:
- •swelling, hardening and tightening; reddened or darkened patches; burning or itching;
- •yellow raised spots on whites of eyes; or
- •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. Patients allergic to any GBCA. Patients with chronic renal disease with a GFR <30 mL/min/1.73 m2 as measured within 30 days prior to the planned OMNISCAN administration. Patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period. Patients that were exposed to any GBCA within a period of 12 months prior the planned index administration of Omniscan.
结局指标
主要结局
To capture post-marketing safety information in patients with moderate renal insufficiency undergoing routine contrast-enhanced MRI with administration of OMNISCAN in order to assess the risk for developing nephrogenic systemic fibrosis. [ Time Frame: Time zero equals the date of Omniscan injection. All subjects will be followed for approximately 2 years after the administration of Omniscan ] [ Designated as safety issue: Yes ]
次要结局
- Development of NSF in 2 years follow up period confirmed histologically(All subjects will be followed for approximately 2 years after the Omniscan administration. Time zero equals the date of Omniscan injection.)