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
- Study HIC#:2000026178
- Last Updated:07/15/2021
The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in patients 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.
- Age18 years and older
- Start Date01/31/2020
- End Date11/30/2020
Trial Purpose and Description
The overall objective of this multicenter, open-label, study is to evaluate the safety and diagnostic efficacy of Mangoral in patients 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 patients 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.
- Male and female patients 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 m2) measured within the screening period, or patients with an increase in serum creatinine ≥ 0.3 mg/dL within 48 hours or ≥ 50% within 7 days
- Any investigational drug or device within 6 weeks prior to the Baseline Visit.
- Any MRI contrast media within 6 weeks prior to Baseline Visit or scheduled to receive any contrast medium before the last study visit.
- Patients with moderate or severe hepatic impairment (according to Child-Pugh score B or C).
- Patients currently requiring dialysis or likely to require dialysis during the course of the clinical trial except designated dialysis patients included in the pharmacokinetic (PK) subgroup.
- Patients scheduled for surgery before last study visit.
- Patients with encephalopathy / neurodegenerative or acute neurological disorders.
- Patients with hemochromatosis, iron deficiency anemia, or are on iron therapy within 14 days prior to the Baseline Visit.