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Trial record 1 of 1 for:    NCT04119843
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Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function (SPARKLE)

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ClinicalTrials.gov Identifier: NCT04119843
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
Ascelia Pharma AB

Tracking Information
First Submitted Date  ICMJE September 29, 2019
First Posted Date  ICMJE October 8, 2019
Last Update Posted Date September 29, 2021
Actual Study Start Date  ICMJE February 19, 2020
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2019)
The primary efficacy endpoint is the visualization of detected focal liver lesions in combined MRI (CMRI, Mangoral-enhanced MRI plus unenhanced MRI) as compared to unenhanced MRI. [ Time Frame: 1 year ]
Visualization will be measured by 2 co-primary variables: lesion border delineation and lesion contrast compared to liver background. Central reading sessions by 3 independent readers for all 3 parts (CMRI, Mangoral-enhanced MRI plus unenhanced MRI). There will be a 2-weeks gap between read parts to reduce recall bias.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2019)
  • Number of lesions detected by each MRI method (unenhanced MRI, Mangoral-enhanced MRI, and CMRI.) [ Time Frame: 1 year ]
    Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination
  • Visualization of focal liver lesions in Mangoral-enhanced MRI as compared to unenhanced MRI [ Time Frame: 1 year ]
    Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination
  • Confidence in lesion detection separately in unenhanced MRI, Mangoral-enhanced MRI, and CMRI [ Time Frame: 1 year ]
    Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination
  • Confidence in lesion localization separately in unenhanced MRI, Mangoral-enhanced MRI, and CMRI [ Time Frame: 1 year ]
    Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination
  • Lesion dimensions: longest diameter of largest and smallest lesion [ Time Frame: 1 year ]
    Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination
  • Quantitative assessments for up to 5 detected lesions (liver signal intensity enhancement; liver-to-lesion contrast; signal-to-noise ratio; contrast-to-noise Ratio) [ Time Frame: 1 year ]
    Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination
  • Change(s) in patients' Management based on diagnostic Performance of CMRI or Mangoral-enhanced MRI vs. unenhanced MRI [ Time Frame: 1 year ]
    Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Multicenter, open-label, pivotal phase III study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Known or Suspected Focal Liver Lesions and Severe Renal Impairment
Intervention  ICMJE Drug: Mangoral
800 mg manganese chloride [II] tetrahydrate, 500 mg L-alanine, and 800 IU vitamin D3
Study Arms  ICMJE Experimental: Mangoral
All participants will receive a single dose of Mangoral (equivalent to 800 mg Manganese (II) chloride tetrahydrate [MnCl2 4H2O]).
Intervention: Drug: Mangoral
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2021)
197
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2019)
200
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karin Liljeberg +46 735 179 112 kl@ascelia.com
Listed Location Countries  ICMJE Argentina,   Germany,   Italy,   Poland,   Russian Federation,   Sweden,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04119843
Other Study ID Numbers  ICMJE ASC-Man-P016
11-3429 ( Other Identifier: FDA Orphan Designation Request )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ascelia Pharma AB
Study Sponsor  ICMJE Ascelia Pharma AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bernd Hamm, MD Charite Berlin, Dept. of Radiology
PRS Account Ascelia Pharma AB
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP