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

Wenzhou Medical University

Status and phase: Unknown; Phase 4

Conditions: Nephrogenic Fibrosing Dermopathy

Treatments: Drug: Gadoteric Acid Meglumine Salt; Drug: Gadodiamide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04776187

Gadolinium 1.0

Details and patient eligibility

About

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.

Full 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).

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Gadodiamide

Active Comparator group

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).

Treatment:

Drug: Gadodiamide

Gadoteric Acid Meglumine Salt

Experimental group

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).

Treatment:

Drug: Gadoteric Acid Meglumine Salt