drugset / 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
Phase 4
Unknown
600 enrolled
The Central Hospital of Lishui City
Jiangsu Hengrui Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupOpen-labelSupportive care
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.
Timeline
- Start
- 2021-03-01
- Primary completion
- 2021-12-31
- Completion
- 2021-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gadodiamide | Diagnostic / imaging agent | 287 mg/ml | — |
| Subject | Gadoteric Acid Meglumine Salt | Diagnostic / imaging agent | 377 mg/ml | — |