CTRI/2009/091/000747招募中4 期
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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
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 be
- •estimated 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:
- •1. skin - swelling, hardening and tightening; reddened or darkened patches; burning or itching;
- •2. eyes - yellow raised spots on whites of eyes; or
- •3. 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.
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