Trial | NCT04119843  Report issue

Title

Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function
A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients With Known or Suspected Focal Liver Lesions and Severe Renal Impairment

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    87
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.
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.
Study Started
Feb 19
2020
Primary Completion
Feb 27
2023
Study Completion
Feb 27
2023
Last Update
Aug 15
2023

Drug Mangoral [manganese chloride, alanine, vitamin d3]

800 mg manganese chloride [II] tetrahydrate, 500 mg L-alanine, and 800 IU vitamin D3

Mangoral Experimental

All participants will receive a single dose of Mangoral (equivalent to 800 mg Manganese (II) chloride tetrahydrate [MnCl2 4H2O]).

Criteria 

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, 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 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 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.
No Results Posted