Clinical trial NCT04776187: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nephrogenic Fibrosing Dermopathy
Keywords: Humans
gadodiamide
MRI
Renal Insufficiency
Drug-Related Adverse Reactions
Lead sponsor: The Central Hospital of Lishui City
Sponsor class: OTHER
Collaborators: name: Jiangsu Hengrui Pharmaceutical Co., Ltd.
First posted: 2021-03-01
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of various adverse events
timeFrame: From the date of contrast injection to the incidence of adverse events, assessd up to 60 minutes
measure: The incidence of various adverse events
timeFrame: From the date of contrast injection to the incidence of adverse events, assessd up to 3 months
measure: The incidence of various adverse events
timeFrame: From the date of contrast injection to the incidence of adverse events, assessd up to 6 months
measure: The incidence of various adverse events
timeFrame: From the date of contrast injection to the incidence of adverse events, assessd up to 12 months
measure: The incidence of various adverse events
timeFrame: From the date of contrast injection to the incidence of adverse events, assessd up to 24 months
Secondary outcomes:
measure: Changes of serum creatinine before and after CE-MRI at 3 days
timeFrame: From the date of contrast injection to the changes of serum creatinine before and after CE-MRI, assessed up to 3 days
measure: Changes of TNF-α before and after CE-MRI at 3 days
timeFrame: From the date of contrast injection to the changes of TNF-α before and after CE-MRI, assessed up to 3 days
measure: Changes of hs-CRP before and after CE-MRI at 3 days
timeFrame: From the date of contrast injection to the changes of hs-CRP before and after CE-MRI, assessed up to 3 days
measure: Changes of IL-6 before and after CE-MRI at 3 days
timeFrame: From the date of contrast injection to the changes of IL-6 before and after CE-MRI, assessed up to 3 days
measure: Evaluation of relevant indicators of skin biopsy
timeFrame: From the date of contrast injection to the clinical manifestations appear, assessed up to 24 months
Other outcomes:
Locations:
city: Lishui
country: China
facility: Lishui Central Hospital
state: Zhejiang
Study officials:
References: