Status:
UNKNOWN
Safety Evaluation of Linear and Macrocyclic Gadolinium Based Contrast Agents for Patients With Mild to Moderate Renal Insufficiency Undergoing Enhanced Magnetic Resonance Imaging
Lead Sponsor:
The Central Hospital of Lishui City
Collaborating Sponsors:
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Conditions:
Nephrogenic Fibrosing Dermopathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 incide...
Detailed Description
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. Obs...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04776187
Start Date
March 1 2021
End Date
December 31 2021
Last Update
March 1 2021
Active Locations (1)
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1
Lishui Central Hospital
Lishui, Zhejiang, China, 323000