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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
Waitlist Available
Research Sponsored by The Central Hospital of Lishui City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of contrast injection to the clinical manifestations appear, assessed up to 24 months
Awards & highlights
Approved for 5 Other Conditions
Pivotal Trial
All Individual Drugs Already Approved
No Placebo-Only Group
Drug Has Already Been Approved
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.
Eligible Conditions
- Nephrogenic Systemic Fibrosis
- Nephrogenic Fibrosing Dermopathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of contrast injection to the clinical manifestations appear, assessed up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of contrast injection to the clinical manifestations appear, assessed up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Evaluation of relevant indicators of skin biopsy
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Gadoteric Acid Meglumine SaltExperimental Treatment1 Intervention
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).
Group II: GadodiamideActive Control1 Intervention
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).
Find a Location
Who is running the clinical trial?
The Central Hospital of Lishui CityLead Sponsor
43 Previous Clinical Trials
527,770 Total Patients Enrolled
Jiangsu Hengrui Pharmaceutical Co., Ltd.Industry Sponsor
28 Previous Clinical Trials
5,200 Total Patients Enrolled