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| Name | Class |
|---|---|
| Jiangsu Hengrui Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gadodiamide | Active Comparator | 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). |
|
| Gadoteric Acid Meglumine Salt | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadodiamide | Drug | Gadodiamide Injection(OMNISCAN™) |
| |
| Gadoteric Acid Meglumine Salt |
| Measure | Description | 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 | |
| The incidence of various adverse events | From the date of contrast injection to the incidence of adverse events, assessd up to 3 months | |
| The incidence of various adverse events | From the date of contrast injection to the incidence of adverse events, assessd up to 6 months | |
| The incidence of various adverse events | From the date of contrast injection to the incidence of adverse events, assessd up to 12 months | |
| The incidence of various adverse events | From the date of contrast injection to the incidence of adverse events, assessd up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiansong S Ji, MD,PhD | Contact | 2285018 | 0578 | lschrjjs@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lishui Central Hospital | Recruiting | Lishui | Zhejiang | 323000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2020 | Jan 11, 2021 |
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| Drug |
Gadoteric Acid Meglumine Salt Injection(Jia Di Xian™) |
|
| 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 | 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 |
| ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2020 | Jan 11, 2021 | Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D054989 | Nephrogenic Fibrosing Dermopathy |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C064925 | gadodiamide |
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