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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-12-31

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.

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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).

Conditions

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Nephrogenic Fibrosing Dermopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Gadodiamide

Intervention Type DRUG

Gadodiamide Injection(OMNISCAN™)

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).

Group Type EXPERIMENTAL

Gadoteric Acid Meglumine Salt

Intervention Type DRUG

Gadoteric Acid Meglumine Salt Injection(Jia Di Xian™)

Interventions

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Gadodiamide

Gadodiamide Injection(OMNISCAN™)

Intervention Type DRUG

Gadoteric Acid Meglumine Salt

Gadoteric Acid Meglumine Salt Injection(Jia Di Xian™)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No