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

NCT ID: NCT04119843

Last Updated: 2025-02-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-19

Study Completion Date

2023-02-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Known or Suspected Focal Liver Lesions Severe Renal Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Multicenter, open-label, pivotal phase III study
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Mangoral

All participants will receive a single dose of Mangoral (800 mg Manganese (II) chloride tetrahydrate \[MnCl2 4H2O\]).

Group Type EXPERIMENTAL

Mangoral

Intervention Type DRUG

800 mg manganese chloride \[II\] tetrahydrate, 500 mg L-alanine, and 800 IU vitamin D3

Interventions

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Mangoral

800 mg manganese chloride \[II\] tetrahydrate, 500 mg L-alanine, and 800 IU vitamin D3

Intervention Type DRUG

Other Intervention Names

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Orviglance CMC-001 ACE-MBCA

Eligibility Criteria

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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, at least once, 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 severe hepatic impairment (according to Child-Pugh score C).
* Participants scheduled for surgery before last study visit.
* Participants with encephalopathy / neurodegenerative or acute neurological disorders.
* Participants with hemochromatosis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ascelia Pharma AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernd Hamm, MD

Role: PRINCIPAL_INVESTIGATOR

Charite Berlin, Dept. of Radiology

Locations

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Mayo Clinic - Arizona

Scottsdale, Arizona, United States

Site Status

University of California at Los Angeles Ronald Reagan Medical Center

Los Angeles, California, United States

Site Status

Stanford University School of Medicine

Stanford, California, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Schiff Center for Liver Diseases

Miami, Florida, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Boston University Medical Center

Boston, Massachusetts, United States

Site Status

Saint Louis University

St Louis, Missouri, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

PanAmerican Clinical Research LLC

Brownsville, Texas, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

University of Wisconsin - Madison

Madison, Wisconsin, United States

Site Status

Fundación Intecnus

Bariloche, Río Negro Province, Argentina

Site Status

Centro Rossi Body Imaging

Buenos Aires, , Argentina

Site Status

Sanatorio Allende Nueva Córdoba

Córdoba, , Argentina

Site Status

Hospital Pablo Tobon Uribe

Medellín, Antioquia, Colombia

Site Status

Clínica Universitaria Colombia

Bogotá, Cundinamarca, Colombia

Site Status

Sociedad de Cirugía de Bogotá - Hospital de San José

Bogotá, Cundinamarca, Colombia

Site Status

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Universitätsklinikum Frankfurt Institut für Diagnostische und Interventionelle Radiologie

Frankfurt, , Germany

Site Status

Universitätsmedizin Göttingen

Göttingen, , Germany

Site Status

Städtisches Klinikum KarlsruheDiagnostische und interventionelle Radiologie

Karlsruhe, , Germany

Site Status

Universitättsklinikum Schleswig-Holstein/Campus KielKlinik für Radiologie und Neuroradiologie

Kiel, , Germany

Site Status

Klinik und Poliklinik für Radiologie Klinikum der Universität München LMU Campus

Munich, , Germany

Site Status

Institut für Röntgendiagnostik

Regensburg, , Germany

Site Status

Azienda Socio Sanitaria Territoriale (ASST)

Milan, Lombardy, Italy

Site Status

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

Bologna, , Italy

Site Status

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status

Ospedale del Mare

Napoli, , Italy

Site Status

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Napoli, , Italy

Site Status

Università Cattolica del Sacro Cuore

Roma, , Italy

Site Status

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Rome, , Italy

Site Status

Ospedale di Belcolle

Viterbo, , Italy

Site Status

Panamerican Clinical Research - Cuernavaca Rio Mayo

Cuernavaca, , Mexico

Site Status

Panamerican Clinical Research Mexico

Guadalajara, , Mexico

Site Status

Panamerican Clinical Research - Querétaro Avenida Paseo de la República

Querétaro, , Mexico

Site Status

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

Bydgoszcz, , Poland

Site Status

Szpital Uniwersytecki w Krakowie Zakład Diagnostyki Obrazowej CUMRiK Ul

Krakow, , Poland

Site Status

EuroMedis Sp. z o.o.

Szczecin, , Poland

Site Status

Altay Regional Oncology Dispencery

Barnaul, , Russia

Site Status

State Institution of Healthcare "Regional Oncology Dispensary"

Irkutsk, , Russia

Site Status

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

Moscow, , Russia

Site Status

A.V. Vishnevsky Institute of Surgery

Moscow, , Russia

Site Status

National Medical Research Radiology Center Named After Herzen

Moscow, , Russia

Site Status

JSC "Avicenna"

Novosibirsk, , Russia

Site Status

State Institution of Healthcare of Omsk region

Omsk, , Russia

Site Status

SBIH of Pskov Regional Clinical Oncologic Dispensary

Pskov, , Russia

Site Status

LLC "Clinica YZI 4D"

Pyatigorsk, , Russia

Site Status

N.N. Petrov Research Institute of Oncology

Saint Petersburg, , Russia

Site Status

Saint-Petersburg State Budgetary Healthcare Institution

Saint Petersburg, , Russia

Site Status

Smolensk Clinical Hospital

Smolensk, , Russia

Site Status

State Autonomous Healthcare Institution of the Tyumen Region

Tyumen, , Russia

Site Status

Karolinska University Hospital Huddinge

Stockholm, , Sweden

Site Status

Ege University Medical Faculty Hospital

Bornova, İzmir, Turkey (Türkiye)

Site Status

Erciyes University Medical Faculty Hospital

Melikgazi, Kayseri, Turkey (Türkiye)

Site Status

Kocaeli University

İzmit, Kocaeli, Turkey (Türkiye)

Site Status

Hacettepe University Medical Faculty Hospital

Ankara, , Turkey (Türkiye)

Site Status

İstanbul Üniversitesi - Istanbul Tıp Fakültesi

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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United States Argentina Colombia Germany Italy Mexico Poland Russia Sweden Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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11-3429

Identifier Type: OTHER

Identifier Source: secondary_id

ASC-Man-P016

Identifier Type: -

Identifier Source: org_study_id

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