EUCTR2019-001599-12-SE
Active, not recruiting
Phase 1
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 - SPARKLE
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ascelia Pharma AB
- Enrollment
- 197
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 at least once 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
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 severe hepatic impairment (according to Child\-Pugh score C).
- •Patients scheduled for surgery before last study visit.
- •Patients with encephalopathy / neurodegenerative or acute neurological disorders.
- •Patients with hemochromatosis
Outcomes
Primary Outcomes
Not specified
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