Back to resultsSafety Evaluation of Linear and Macrocyclic Gadolinium Based Contrast Agents for Patients With Mild to Moderate Renal Insufficiency Undergoing Enhanced Magnetic Resonance Imaging
Primary Purpose
Nephrogenic Fibrosing Dermopathy
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Gadodiamide
Gadoteric Acid Meglumine Salt
Sponsored by
About this trial
This is an interventional supportive care trial for Nephrogenic Fibrosing Dermopathy focused on measuring Humans, gadodiamide, MRI, Renal Insufficiency, Drug-Related Adverse Reactions
Eligibility Criteria
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.
Sites / Locations
- Lishui Central HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Gadodiamide
Gadoteric Acid Meglumine Salt
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
The incidence of various adverse events
The incidence of various adverse events
The incidence of various adverse events
The incidence of various adverse events
The incidence of various adverse events
Secondary Outcome Measures
Changes of serum creatinine before and after CE-MRI at 3 days
Changes of TNF-α before and after CE-MRI at 3 days
Changes of hs-CRP before and after CE-MRI at 3 days
Changes of IL-6 before and after CE-MRI at 3 days
Evaluation of relevant indicators of skin biopsy
proliferation of fibroblasts in subcutaneous tissue, thickening of collagen fiber bundles
Full Information
NCT ID
NCT04776187
First Posted
January 11, 2021
Last Updated
February 26, 2021
Sponsor
The Central Hospital of Lishui City
Collaborators
Jiangsu Hengrui Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04776187
Brief Title
Safety Evaluation of Linear and Macrocyclic Gadolinium Based Contrast Agents for Patients With Mild to Moderate Renal Insufficiency Undergoing Enhanced Magnetic Resonance Imaging
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Central Hospital of Lishui City
Collaborators
Jiangsu Hengrui Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrogenic Fibrosing Dermopathy
Keywords
Humans, gadodiamide, MRI, Renal Insufficiency, Drug-Related Adverse Reactions
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gadodiamide
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Gadoteric Acid Meglumine Salt
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Gadodiamide
Intervention Description
Gadodiamide Injection(OMNISCAN™)
Intervention Type
Drug
Intervention Name(s)
Gadoteric Acid Meglumine Salt
Intervention Description
Gadoteric Acid Meglumine Salt Injection(Jia Di Xian™)
Primary Outcome Measure Information:
Title
The incidence of various adverse events
Time Frame
From the date of contrast injection to the incidence of adverse events, assessd up to 60 minutes
Title
The incidence of various adverse events
Time Frame
From the date of contrast injection to the incidence of adverse events, assessd up to 3 months
Title
The incidence of various adverse events
Time Frame
From the date of contrast injection to the incidence of adverse events, assessd up to 6 months
Title
The incidence of various adverse events
Time Frame
From the date of contrast injection to the incidence of adverse events, assessd up to 12 months
Title
The incidence of various adverse events
Time Frame
From the date of contrast injection to the incidence of adverse events, assessd up to 24 months
Secondary Outcome Measure Information:
Title
Changes of serum creatinine before and after CE-MRI at 3 days
Time Frame
From the date of contrast injection to the changes of serum creatinine before and after CE-MRI, assessed up to 3 days
Title
Changes of TNF-α before and after CE-MRI at 3 days
Time Frame
From the date of contrast injection to the changes of TNF-α before and after CE-MRI, assessed up to 3 days
Title
Changes of hs-CRP before and after CE-MRI at 3 days
Time Frame
From the date of contrast injection to the changes of hs-CRP before and after CE-MRI, assessed up to 3 days
Title
Changes of IL-6 before and after CE-MRI at 3 days
Time Frame
From the date of contrast injection to the changes of IL-6 before and after CE-MRI, assessed up to 3 days
Title
Evaluation of relevant indicators of skin biopsy
Description
proliferation of fibroblasts in subcutaneous tissue, thickening of collagen fiber bundles
Time Frame
From the date of contrast injection to the clinical manifestations appear, assessed up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiansong S Ji, MD,PhD
Phone
2285018
Ext
0578
Email
lschrjjs@163.com
Facility Information:
Facility Name
Lishui Central Hospital
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiansong S Ji, MD,PhD
Phone
2285018
Ext
0578
Email
lschrjjs@163.com
12. IPD Sharing Statement
Learn more about this trial
Safety Evaluation of Linear and Macrocyclic Gadolinium Based Contrast Agents for Patients With Mild to Moderate Renal Insufficiency Undergoing Enhanced Magnetic Resonance Imaging
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