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Clinical Trial 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.


Clinical Trial 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. 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04776187
Study type Interventional
Source The Central Hospital of Lishui City
Contact Jiansong S Ji, MD,PhD
Phone 2285018
Email lschrjjs@163.com
Status Recruiting
Phase Phase 4
Start date March 1, 2021
Completion date December 31, 2021

See also
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Completed NCT01014754 - Nephrogenic Systemic Fibrosis (NSF): Analysis of Tissue Gadolinium Levels N/A