Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function
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.
- Known or Suspected Focal Liver Lesions and Severe Renal Impairment
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.
- Phase 3
- Study Type
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Multicenter, open-label, pivotal phase III study
- Primary Purpose
- None (Open Label)
|All participants will receive a single dose of Mangoral (equivalent to 800 mg Manganese (II) chloride tetrahydrate [MnCl2 4H2O]).||
- Ascelia Pharma AB
Study ContactKarin Liljeberg
+46 735 179 112
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.