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 1

• Conditions: MRI in terms of visualization of detected focal liver lesions in patients with known or Suspected focal liver lesions and severe renal impairment; MedDRA version: 22.1Level: LLTClassification code 10028049Term: MRISystem Organ Class: 100000004848; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2019-001599-12-PL
• Lead Sponsor: Ascelia Pharma AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-07
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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 such as:
a. Chronic kidney disease [CKD] (estimated glomerular filtrationrate [eGFR] < 30 mL/min/1.73 m2) based on medical history and previous laboratory examinations within the last 3 months prior to the Baseline Visit, OR

b. Acute kidney injury (AKI) with an increase in serum creatinine = 0.3 mg/dL within 48 hours or = 50% within 7 days prior to the Baseline Visit

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Patients with simple liver cysts only
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 PK subgroup.
Patients scheduled for surgery before last study visit.
Patients with encephalopathy / neurodegenerative or acute neurological disorders.
Patients with hemochromatosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified