← Back to Search

Gadoteric Acid Meglumine Salt for Nephrogenic Systemic Fibrosis

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

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

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).

Do I qualify?Apply below to find out