A Phase 4 interventional study of Gadodiamide and Gadoteric Acid Meglumine Salt in Nephrogenic Fibrosing Dermopathy, sponsored by The Central Hospital of Lishui City. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-01.
Sponsored by The Central Hospital of Lishui City · Phase 4, Interventional, and Supportive care
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.
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).
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's planned enrollment of 600 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →The Central Hospital of Lishui City is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Gadodiamide Injection(OMNISCAN™)
Gadoteric Acid Meglumine Salt Injection(Jia Di Xian™)
The incidence of various adverse events
Time frame: From the date of contrast injection to the incidence of adverse events, assessd up to 60 minutes
The incidence of various adverse events
Time frame: From the date of contrast injection to the incidence of adverse events, assessd up to 3 months
The incidence of various adverse events
Time frame: From the date of contrast injection to the incidence of adverse events, assessd up to 6 months
The incidence of various adverse events
Time frame: From the date of contrast injection to the incidence of adverse events, assessd up to 12 months
The incidence of various adverse events
Time frame: From the date of contrast injection to the incidence of adverse events, assessd up to 24 months
Changes of serum creatinine before and after CE-MRI at 3 days
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the date of contrast injection to the clinical manifestations appear, assessed up to 24 months
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The Central Hospital of Lishui City