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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Nephrogenic Fibrosing Dermopathy

Intervention / Treatment
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* Drug: Gadodiamide
* Drug: Gadoteric Acid Meglumine Salt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gadodiamide<br>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). | Drug: Gadodiamide<br>* Gadodiamide Injection(OMNISCAN™)<br>|
| Experimental: Gadoteric Acid Meglumine Salt<br>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). | Drug: Gadoteric Acid Meglumine Salt<br>* Gadoteric Acid Meglumine Salt Injection(Jia Di Xian™)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of various adverse events |  | From the date of contrast injection to the incidence of adverse events, assessd up to 60 minutes | 
| The incidence of various adverse events |  | From the date of contrast injection to the incidence of adverse events, assessd up to 3 months | 
| The incidence of various adverse events |  | From the date of contrast injection to the incidence of adverse events, assessd up to 6 months | 
| The incidence of various adverse events |  | From the date of contrast injection to the incidence of adverse events, assessd up to 12 months | 
| The incidence of various adverse events |  | From the date of contrast injection to the incidence of adverse events, assessd up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 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 | 
| 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 | 
| Evaluation of relevant indicators of skin biopsy | proliferation of fibroblasts in subcutaneous tissue, thickening of collagen fiber bundles | From the date of contrast injection to the clinical manifestations appear, assessed up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Humans, gadodiamide, MRI, Renal Insufficiency, Drug-Related Adverse Reactions