Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function

Last updated: January 15, 2025
Sponsor: Ascelia Pharma AB
Overall Status: Completed

Phase

3

Condition

Kidney Failure

Renal Failure

Nephropathy

Treatment

Mangoral

Clinical Study ID

NCT04119843
ASC-Man-P016
11-3429
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female participants 18 years and older.

  • Known or suspected focal liver lesions based on medical history and previouslaboratory and/or imaging examinations.

  • Severe renal impairment (estimated glomerular filtration rate [eGFR] < 30mL/min/1.73 m^2) based on medical history and previous laboratory examinations, atleast once, within the last 3 months prior to the Baseline Visit, or participantswith an increase in serum creatinine ≥ 0.3 mg/dL within 48 hours or ≥ 50% within 7days prior to the Baseline Visit.

Exclusion

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 BaselineVisit or scheduled to receive any contrast medium before the last study visit.

  • Participants with severe hepatic impairment (according to Child-Pugh score C).

  • Participants scheduled for surgery before last study visit.

  • Participants with encephalopathy / neurodegenerative or acute neurologicaldisorders.

  • Participants with hemochromatosis.

Study Design

Total Participants: 87
Treatment Group(s): 1
Primary Treatment: Mangoral
Phase: 3
Study Start date:
February 19, 2020
Estimated Completion Date:
February 17, 2023

Study 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.

Connect with a study center

  • Fundación Intecnus

    San Carlos De Bariloche, Río Negro R8405AZA
    Argentina

    Site Not Available

  • Centro Rossi Body Imaging

    Buenos Aires, C1425 BEE
    Argentina

    Site Not Available

  • Sanatorio Allende Nueva Córdoba

    Cordoba, X5000JHQ
    Argentina

    Site Not Available

  • Hospital Pablo Tobon Uribe

    Medellín, Antioquia 69-240
    Colombia

    Site Not Available

  • Clínica Universitaria Colombia

    Bogotá, Cundinamarca 111221
    Colombia

    Site Not Available

  • Sociedad de Cirugía de Bogotá - Hospital de San José

    Bogotá, Cundinamarca 111611
    Colombia

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin,
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt Institut für Diagnostische und Interventionelle Radiologie

    Frankfurt, 60590
    Germany

    Site Not Available

  • Universitätsmedizin Göttingen

    Göttingen,
    Germany

    Site Not Available

  • Städtisches Klinikum KarlsruheDiagnostische und interventionelle Radiologie

    Karlsruhe, 76227
    Germany

    Site Not Available

  • Universitättsklinikum Schleswig-Holstein/Campus KielKlinik für Radiologie und Neuroradiologie

    Kiel, 24105
    Germany

    Site Not Available

  • Klinik und Poliklinik für Radiologie Klinikum der Universität München LMU Campus

    Munich, 81377
    Germany

    Site Not Available

  • Institut für Röntgendiagnostik

    Regensburg, 93053
    Germany

    Site Not Available

  • Azienda Socio Sanitaria Territoriale (ASST)

    Milano, Lombardy 20157
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola-Malpighi

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Site Not Available

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Napoli,
    Italy

    Site Not Available

  • Ospedale del Mare

    Napoli, 80147
    Italy

    Site Not Available

  • Università Cattolica del Sacro Cuore

    Roma, 00168
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I

    Rome, 00161
    Italy

    Site Not Available

  • Ospedale di Belcolle

    Viterbo, 01100
    Italy

    Site Not Available

  • Panamerican Clinical Research - Cuernavaca Rio Mayo

    Cuernavaca, 62290
    Mexico

    Site Not Available

  • Panamerican Clinical Research Mexico

    Guadalajara, 44670
    Mexico

    Site Not Available

  • Panamerican Clinical Research - Querétaro Avenida Paseo de la República

    Querétaro, 76230
    Mexico

    Site Not Available

  • Szpital Uniwersytecki nr 1 im. Dr A. Jurasza, Wydział Katedra i Zakład Radiologii i Diagnostyki Obrazowej

    Bydgoszcz,
    Poland

    Site Not Available

  • Szpital Uniwersytecki w Krakowie Zakład Diagnostyki Obrazowej CUMRiK Ul

    Kraków, 31-501
    Poland

    Site Not Available

  • EuroMedis Sp. z o.o.

    Szczecin, 70-111
    Poland

    Site Not Available

  • Radio Medica

    Warszawa, 00-728
    Poland

    Site Not Available

  • Altay Regional Oncology Dispencery

    Barnaul, Zmeigorsky trakt 110
    Russian Federation

    Site Not Available

  • State Institution of Healthcare "Regional Oncology Dispensary"

    Irkutsk, 664035
    Russian Federation

    Site Not Available

  • A.V. Vishnevsky Institute of Surgery

    Moscow, 117997
    Russian Federation

    Site Not Available

  • National Medical Research Radiology Center Named After Herzen

    Moscow, 125284
    Russian Federation

    Site Not Available

  • Scientific and Research Institute of Oncology named after N.N. Blokhin

    Moscow, 115478
    Russian Federation

    Site Not Available

  • JSC "Avicenna"

    Novosibirsk, 630099
    Russian Federation

    Site Not Available

  • State Institution of Healthcare of Omsk region

    Omsk, 644013
    Russian Federation

    Site Not Available

  • SBIH of Pskov Regional Clinical Oncologic Dispensary

    Pskov, 180004
    Russian Federation

    Site Not Available

  • LLC "Clinica YZI 4D"

    Pyatigorsk, 357500
    Russian Federation

    Site Not Available

  • N.N. Petrov Research Institute of Oncology

    Saint Petersburg, 197758
    Russian Federation

    Site Not Available

  • Saint-Petersburg State Budgetary Healthcare Institution

    Saint Petersburg, 198255
    Russian Federation

    Site Not Available

  • Smolensk Clinical Hospital

    Smolensk, 214006
    Russian Federation

    Site Not Available

  • State Autonomous Healthcare Institution of the Tyumen Region

    Tyumen, 625033
    Russian Federation

    Site Not Available

  • Karolinska University Hospital Huddinge

    Stockholm,
    Sweden

    Site Not Available

  • Erciyes University Medical Faculty Hospital

    Melikgazi, Kayseri 38030
    Turkey

    Site Not Available

  • Kocaeli University

    İzmit, Kocaeli 41001
    Turkey

    Site Not Available

  • Ege University Medical Faculty Hospital

    Bornova, İzmir 35100
    Turkey

    Site Not Available

  • Hacettepe University Medical Faculty Hospital

    Ankara, 06230
    Turkey

    Site Not Available

  • İstanbul Üniversitesi - Istanbul Tıp Fakültesi

    Istanbul, 34093
    Turkey

    Site Not Available

  • Mayo Clinic - Arizona

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • University of California at Los Angeles Ronald Reagan Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • Stanford University School of Medicine

    Stanford, California 94305
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Schiff Center for Liver Diseases

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Louisiana State University

    Baton Rouge, Louisiana 70803
    United States

    Site Not Available

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Boston University Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Mayo Clinic - Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Saint Louis University

    Saint Louis, Missouri 63103
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • PanAmerican Clinical Research LLC

    Brownsville, Texas 78521
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

  • University of Wisconsin - Madison

    Madison, Wisconsin 53792
    United States

    Site Not Available

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