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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nephrogenic Fibrosing Dermopathy
• Intervention / Treatment: Drug: Gadodiamide; Drug: Gadoteric Acid Meglumine Salt

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).

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jiansong S Ji, MD,PhD; Phone Number: 0578 2285018; Email: lschrjjs@163.com

Study Locations

• China
  • Zhejiang
    • Lishui, Zhejiang, China, 323000
      • Recruiting
      • Lishui Central Hospital
      • Contact: Jiansong S Ji, MD,PhD; Phone Number: 0578 2285018; Email: lschrjjs@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gadodiamide; 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; Gadodiamide Injection(OMNISCAN™)
Experimental: Gadoteric Acid Meglumine Salt; 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; Gadoteric Acid Meglumine Salt Injection(Jia Di Xian™)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The Central Hospital of Lishui City
• Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: MRI; Humans; Renal Insufficiency; gadodiamide; Drug-Related Adverse Reactions
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Kidney Diseases; Urologic Diseases; Fibrosis; Renal Insufficiency; Nephrogenic Fibrosing Dermopathy
• Other Study ID Numbers: Gadolinium 1.0

Drug and device information, study documents

• 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