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

NCT01467271 | Completed Results

• 1 other identifier: DGD-55-003
• Study Type: observational
• Target: 540
• Locations: 11 countries
• Sites: 27

Brief Summary

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®

Conditions

Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem

  All patients were followed up during 2 years after Dotarem administration.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patients with moderate to severe and end stage renal impairment or dialysis * Patients scheduled for a contrast-enhanced MRI with Dotarem

You may qualify if:

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

Sponsors & Collaborators

• Guerbet: lead

Study Sites (27)

Covenant Health Care

Saginaw, Michigan, United States

Location

St. Louis University Medical Center

St Louis, Missouri, United States

Location

Abington Memorial Hospital

Philadelphia, Pennsylvania, United States

Location

University of Texas Health Science Center

San Antonio, Texas, United States

Location

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Location

UZ Brussel

Brussels, Belgium

Location

AZ St Lucas

Ghent, Belgium

Location

H. Hartziekenhuis

Roeselare, Belgium

Location

Hospital Universitario de San Ignacio

Bogotá, Colombia

Location

IATM (Instituto de alta tecnologia Medica de Antoquia)

Medellín, Colombia

Location

Hôpital Necker - Enfants malades

Paris, France

Location

Hôpital Bois-Guillaume - CHU de Rouen

Rouen, France

Location

Cardioangiologisches Centrum Bethanien

Frankfurt, Germany

Location

Institute of Radiology and Neuroradiology

Frankfurt, Germany

Location

Instituto Tumori Pascale

Napoli, Italy

Location

Ospedale Santa Maria

Pozzuoli, Italy

Location

Universita campus Biomedico

Roma, Italy

Location

Soonchunhyang Univ. Bucheon Hospital

Gyeonggi-do, South Korea

Location

Uijeongbu St. Mary's Hospital

Gyeonggi-do, South Korea

Location

Chung-Ang Univ. Medical Center

Seoul, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Hospital Clínico San Carlos de Madrid

Madrid, Spain

Location

CRC Hospital Universitari Sant Joan de Reus

Reus, Spain

Location

Dişkapi Etlik Polikliniği

Ankara, Turkey (Türkiye)

Location

Medeniyet University Goztepe Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Royal Liverpool University Hospital

Liverpool, United Kingdom

Location

University Hospital of North Staffodshire

Stoke-on-Trent, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Corinne Dubourdieu, Head of Clinical Projects and Medical Writing
• Organization: Guerbet

corinne.dubourdieu@guerbet.com

+33(0)1 45 91 50 00

Study Officials

• Pierre Desché, MD

  Guerbet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: November 8, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 4, 2019
• Results First Posted: February 4, 2019

Record last verified: 2018-09

Locations

CO (2); BE (3); KR (4); AR (1); ES (2); US (4); IT (3); TU (2); GB (2); FR (2); DE (2)