Nephrogenic Fibrosing Dermopathy Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Lishui Central Hospital | Lishui | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
The Central Hospital of Lishui City | Jiangsu Hengrui Pharmaceutical Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of various adverse events | From the date of contrast injection to the incidence of adverse events, assessd up to 60 minutes | ||
Primary | The incidence of various adverse events | From the date of contrast injection to the incidence of adverse events, assessd up to 3 months | ||
Primary | The incidence of various adverse events | From the date of contrast injection to the incidence of adverse events, assessd up to 6 months | ||
Primary | The incidence of various adverse events | From the date of contrast injection to the incidence of adverse events, assessd up to 12 months | ||
Primary | The incidence of various adverse events | From the date of contrast injection to the incidence of adverse events, assessd up to 24 months | ||
Secondary | 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 | ||
Secondary | Changes of TNF-a before and after CE-MRI at 3 days | From the date of contrast injection to the changes of TNF-a before and after CE-MRI, assessed up to 3 days | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Evaluation of relevant indicators of skin biopsy | proliferation of fibroblasts in subcutaneous tissue, thickening of collagen fiber bundles | From the date of contrast injection to the clinical manifestations appear, assessed up to 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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