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

Nephrogenic Fibrosing Dermopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04776187
• Other study ID #: Gadolinium 1.0
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: The Central Hospital of Lishui City
• Contact: Jiansong S Ji, MD,PhD
• Phone: 2285018
• Email: lschrjjs[@]163.com
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nephrogenic Fibrosing Dermopathy
• Renal Insufficiency

Intervention

Drug:
• Gadodiamide
Gadodiamide Injection(OMNISCAN™)
• Gadoteric Acid Meglumine Salt
Gadoteric Acid Meglumine Salt Injection(Jia Di Xian™)

Locations

Country	Name	City	State
China	Lishui Central Hospital	Lishui	Zhejiang

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of various adverse events		From the date of contrast injection to the incidence of adverse events, assessd up to 60 minutes
Primary	The incidence of various adverse events		From the date of contrast injection to the incidence of adverse events, assessd up to 3 months
Primary	The incidence of various adverse events		From the date of contrast injection to the incidence of adverse events, assessd up to 6 months
Primary	The incidence of various adverse events		From the date of contrast injection to the incidence of adverse events, assessd up to 12 months
Primary	The incidence of various adverse events		From the date of contrast injection to the incidence of adverse events, assessd up to 24 months
Secondary	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
Secondary	Changes of TNF-a before and after CE-MRI at 3 days		From the date of contrast injection to the changes of TNF-a before and after CE-MRI, assessed up to 3 days
Secondary	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
Secondary	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
Secondary	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