Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function

  • STATUS
    Recruiting
  • days left to enroll
    57
  • participants needed
    197
  • sponsor
    Ascelia Pharma AB
Updated on 23 July 2021

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. The diagnostic efficacy of Mangoral will be assessed in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI.

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 impairment. Study treatment is a single oral dose of Mangoral (800 mg manganese chloride [II] tetrahydrate, 500 mg L-alanine, and 800 IU vitamin D3). Adult male and female participants with severe renal impairment or acute kidney injury and who are being evaluated for known or suspected focal liver lesions will be included. Primary diagnostic efficacy in terms of visualization of detected lesions will be evaluated centrally by 3 independent readers. Study MRIs will also be evaluated by the on-site radiologists for the assessment of secondary objectives and for clinical purposes.

Details
Condition Known or Suspected Focal Liver Lesions and Severe Renal Impairment
Treatment Mangoral
Clinical Study IdentifierNCT04119843
SponsorAscelia Pharma AB
Last Modified on23 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 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 Criteria

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 moderate or severe hepatic impairment (according to Child-Pugh score B or C)
Participants currently requiring dialysis or likely to require dialysis during the course of the clinical trial except designated dialysis participants included in the pharmacokinetic (PK) subgroup
Participants scheduled for surgery before last study visit
Participants with encephalopathy / neurodegenerative or acute neurological disorders
Participants with hemochromatosis
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