Safety Evaluation of Linear and Macrocyclic Gadolinium-Based Contrast Agents for Patients With Mild to Moderate Renal Insufficiency Undergoing Enhanced Magnetic Resonance Imaging (Interventional Prospective Study) Clinical Trial Protocol
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- The incidence of various adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety of linear and macrocyclic gadolinium-based contrast agents for patients with mild to moderate renal insufficiency. The study will compare the incidence of adverse events of gadodiamide and gadoteric Acid Meglumine Salt for patients with mild to moderate renal insufficiency undergoing enhanced magnetic resonance imaging.
详细描述
According to the requirements of the study, 600 cases of patients with mild to moderate renal insufficiency were enrolled. Gadodiamide and Gadoteric acid meglumine salt were used for enhanced MRI. Observe the adverse reactions within 60 minutes of using the gadolinium contrast agents; follow up by telephone at 3, 6, 12, and 24 months after the inspection. The primary endpoint is the incidence of the various adverse events, and the secondary endpoints are changes of serum creatinine and inflammatory factors (TNF-α, hs-CRP, IL-6) before and after CE-MRI, patient skin examination and evaluation (evaluation of relevant indicators of skin biopsy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 80 years old who require gadolinium-based CE-MRI;
- •Patients with renal function 30ml/min/1.73m2≤eGFR<90/min/1.73m2;
- •Patients who are able and willing to comply with the required inspection requirements.
排除标准
- •Patient who experienced allergic reactions to previous gadolinium-based contrast agents;
- •Patient who had used gadolinium-based contrast agents within 3 months;
- •Patient with acute renal failure;
- •Patient who cannot comply with or cannot tolerate the necessary fluid replenishment procedures;
- •Patient with major mental illness, impaired consciousness, or other diseases considered by researchers to affect observation.
研究组 & 干预措施
Gadodiamide
Patients who have undergone contrast-enhanced MRI using Gadodiamide contrast agent for clinical purposes.
Generic name: Gadodiamide Injection; Product name: OMNISCAN; Sample specifications: 15ml: 4.305g (a sterile solution containing 287mg/ml gadodiamide).
干预措施: Gadodiamide (Drug)
Gadoteric Acid Meglumine Salt
Patients who have undergone contrast-enhanced MRI using Gadoteric Acid Meglumine Salt contrast agent for clinical purposes.
Generic name: Gadoteric Acid Meglumine Salt Injection; Commodity name: Jia Di Xian; Sample specifications: 15ml: 5.654g (a sterile solution containing 377mg/ml gadoteric acid meglumine salt).
干预措施: Gadoteric Acid Meglumine Salt (Drug)
结局指标
主要结局
The incidence of various adverse events
时间窗: From the date of contrast injection to the incidence of adverse events, assessd up to 24 months
次要结局
- Changes of IL-6 before and after CE-MRI at 3 days(From the date of contrast injection to the changes of IL-6 before and after CE-MRI, assessed up to 3 days)
- Changes of TNF-α before and after CE-MRI at 3 days(From the date of contrast injection to the changes of TNF-α before and after CE-MRI, assessed up to 3 days)
- Changes of serum creatinine before and after CE-MRI at 3 days(From the date of contrast injection to the changes of serum creatinine before and after CE-MRI, assessed up to 3 days)
- Evaluation of relevant indicators of skin biopsy(From the date of contrast injection to the clinical manifestations appear, assessed up to 24 months)
- Changes of hs-CRP before and after CE-MRI at 3 days(From the date of contrast injection to the changes of hs-CRP before and after CE-MRI, assessed up to 3 days)