Safety Evaluation of Linear and Macrocyclic Gadolinium Based Contrast Agents for Patients With Mild to Moderate Renal Insufficiency Undergoing Enhanced Magnetic Resonance Imaging

NCT04776187 | Unknown Phase 4

• 1 other identifier: Gadolinium 1.0
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nephrogenic Fibrosing Dermopathy

Keywords

Humans; gadodiamide; MRI; Renal Insufficiency; Drug-Related Adverse Reactions

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (5)

• 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

• 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

  From the date of contrast injection to the clinical manifestations appear, assessed up to 24 months

Study Arms (2)

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).

Drug: 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).

Drug: Gadoteric Acid Meglumine Salt

Interventions

Gadodiamide DRUG

Gadodiamide Injection(OMNISCAN™)

Gadodiamide

Gadoteric Acid Meglumine Salt DRUG

Gadoteric Acid Meglumine Salt Injection(Jia Di Xian™)

Gadoteric Acid Meglumine Salt

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 80 years old who require gadolinium-based CE-MRI;
• Patients with renal function 30ml/min/1.73m2≤eGFR\<90/min/1.73m2;
• Patients who are able and willing to comply with the required inspection requirements.

You may not qualify if:

• Patient who experienced allergic reactions to previous gadolinium-based contrast agents;
• Patient who had used gadolinium-based contrast agents within 3 months;
• Patient with acute renal failure;
• Patient who cannot comply with or cannot tolerate the necessary fluid replenishment procedures;
• Patient with major mental illness, impaired consciousness, or other diseases considered by researchers to affect observation.

Sponsors & Collaborators

• The Central Hospital of Lishui City: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Lishui Central Hospital

Lishui, Zhejiang, 323000, China

RECRUITING

MeSH Terms

Conditions

Nephrogenic Fibrosing Dermopathy; Renal Insufficiency

Interventions

gadodiamide

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Jiansong S Ji, MD,PhD

CONTACT

2285018; lschrjjs@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: March 1, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 1, 2021

Record last verified: 2021-02

Locations

CN (1)