Status:
COMPLETED
Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function
Lead Sponsor:
Ascelia Pharma AB
Conditions:
Known or Suspected Focal Liver Lesions
Severe Renal Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment. ...
Detailed Description
The overall objective of this multicenter, open-label, study is to evaluate the safety and diagnostic efficacy of Mangoral in participants with known or suspected focal liver lesions and severe renal ...
Eligibility Criteria
Inclusion
- Male and female participants 18 years and older.
- Known or suspected focal liver lesions based on medical history and previous laboratory and/or imaging examinations.
- Severe renal impairment (estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73 m\^2) based on medical history and previous laboratory examinations, at least once, within the last 3 months prior to the Baseline Visit, or participants with an increase in serum creatinine ≥ 0.3 mg/dL within 48 hours or ≥ 50% within 7 days prior to the Baseline Visit.
Exclusion
- Participants with simple liver cysts only.
- Any investigational drug or device within 6 weeks prior to the Baseline Visit.
- Any magnetic resonance imaging (MRI) contrast media within 6 weeks prior to Baseline Visit or scheduled to receive any contrast medium before the last study visit.
- Participants with severe hepatic impairment (according to Child-Pugh score C).
- Participants scheduled for surgery before last study visit.
- Participants with encephalopathy / neurodegenerative or acute neurological disorders.
- Participants with hemochromatosis.
Key Trial Info
Start Date :
February 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2023
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04119843
Start Date
February 19 2020
End Date
February 17 2023
Last Update
February 6 2025
Active Locations (60)
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1
Mayo Clinic - Arizona
Scottsdale, Arizona, United States, 85259
2
University of California at Los Angeles Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
3
Stanford University School of Medicine
Stanford, California, United States, 94305
4
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224