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Gadoteric Acid Meglumine Salt for Nephrogenic Fibrosing Dermopathy

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

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 Fibrosing Dermopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of contrast injection to the clinical manifestations appear, assessed up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of contrast injection to the clinical manifestations appear, assessed up to 24 months for reporting.

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

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).

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Who is running the clinical trial?

The Central Hospital of Lishui CityLead Sponsor
41 Previous Clinical Trials
26,874 Total Patients Enrolled
Jiangsu Hengrui Pharmaceutical Co., Ltd.Industry Sponsor
27 Previous Clinical Trials
5,171 Total Patients Enrolled
~133 spots leftby Sep 2025
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