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Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration

NCT ID: NCT01467271

Last Updated: 2019-02-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

540 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2017-06-30

Brief Summary

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The main purpose of this study is to prospectively estimate the incidence of Nephrogenic Systemic Fibrosis (NSF) in patients with moderate to severe renal impairment after administration of Dotarem®

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Detailed Description

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All patients will be followed up during 2 years after Dotarem® administration to collect data on any suspected NSF or NSF-related symptoms

Conditions

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Renal Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with moderate to severe and end stage renal impairment or dialysis, scheduled for a contrast-enhanced Magnetic Resonance Imaging (MRI) with Dotarem

Exclusion Criteria

* Patient who has received a Gadolinium Based Contrast Agent (GBCA) within the past 12 months prior to inclusion in this study except if the GBCA received is Dotarem
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guerbet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Desché, MD

Role: STUDY_DIRECTOR

Guerbet

Locations

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Covenant Health Care

Saginaw, Michigan, United States

Site Status

St. Louis University Medical Center

St Louis, Missouri, United States

Site Status

Abington Memorial Hospital

Philadelphia, Pennsylvania, United States

Site Status

University of Texas Health Science Center

San Antonio, Texas, United States

Site Status

Hospital Italiano de Buenos Aires

Buenos Aires, , Argentina

Site Status

UZ Brussel

Brussels, , Belgium

Site Status

AZ St Lucas

Ghent, , Belgium

Site Status

H. Hartziekenhuis

Roeselare, , Belgium

Site Status

Hospital Universitario de San Ignacio

Bogotá, , Colombia

Site Status

IATM (Instituto de alta tecnologia Medica de Antoquia)

Medellín, , Colombia

Site Status

Hôpital Necker - Enfants malades

Paris, , France

Site Status

Hôpital Bois-Guillaume - CHU de Rouen

Rouen, , France

Site Status

Cardioangiologisches Centrum Bethanien

Frankfurt, , Germany

Site Status

Institute of Radiology and Neuroradiology

Frankfurt, , Germany

Site Status

Instituto Tumori Pascale

Napoli, , Italy

Site Status

Ospedale Santa Maria

Pozzuoli, , Italy

Site Status

Universita campus Biomedico

Roma, , Italy

Site Status

Soonchunhyang Univ. Bucheon Hospital

Gyeonggi-do, , South Korea

Site Status

Uijeongbu St. Mary's Hospital

Gyeonggi-do, , South Korea

Site Status

Chung-Ang Univ. Medical Center

Seoul, , South Korea

Site Status

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status

Hospital Clínico San Carlos de Madrid

Madrid, , Spain

Site Status

CRC Hospital Universitari Sant Joan de Reus

Reus, , Spain

Site Status

Dişkapi Etlik Polikliniği

Ankara, , Turkey (Türkiye)

Site Status

Medeniyet University Goztepe Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Royal Liverpool University Hospital

Liverpool, , United Kingdom

Site Status

University Hospital of North Staffodshire

Stoke-on-Trent, , United Kingdom

Site Status

Countries

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United States Argentina Belgium Colombia France Germany Italy South Korea Spain Turkey (Türkiye) United Kingdom

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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DGD-55-003

Identifier Type: -

Identifier Source: org_study_id

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