Nephrogenic Fibrosing Dermopathy
Conditions
Keywords
Humans, gadodiamide, MRI, Renal Insufficiency, Drug-Related Adverse Reactions
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).
Interventions
DRUGGadodiamide
Gadodiamide Injection(OMNISCAN™)
DRUGGadoteric Acid Meglumine Salt
Gadoteric Acid Meglumine Salt Injection(Jia Di Xian™)
Sponsors
Jiangsu Hengrui Pharmaceutical Co., Ltd.
The Central Hospital of Lishui City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From the date of contrast injection to the clinical manifestations appear, assessed up to 24 months | proliferation of fibroblasts in subcutaneous tissue, thickening of collagen fiber bundles |
Countries
China
Contacts
Primary ContactJiansong S Ji, MD,PhD
Outcome results
None listed