Safety Evaluation of Linear and Macrocyclic Gadolinium Based Contrast Agents for Patients With Mild to Moderate Renal Insufficiency Undergoing Enhanced Magnetic Resonance Imaging

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Central Hospital of Lishui City
• Collaborator: Jiangsu Hengrui Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

1. Patients aged 18 to 80 years old who require gadolinium-based CE-MRI;

2. Patients with renal function 30ml/min/1.73m2≤eGFR<90/min/1.73m2;

3. Patients who are able and willing to comply with the required inspection requirements.

Exclusion Criteria:

1. Patient who experienced allergic reactions to previous gadolinium-based contrast agents;

2. Patient who had used gadolinium-based contrast agents within 3 months;

3. Patient with acute renal failure;

4. Patient who cannot comply with or cannot tolerate the necessary fluid replenishment procedures;

5. Patient with major mental illness, impaired consciousness, or other diseases considered by researchers to affect observation.