Clinical trial NCT00908596: Primovist / Eovist in Renally Impaired Patients
Official title: Prospective Non-randomized (Pharmacoepidemiologic) Cohort Study (Open-label, Multicenter) to Assess the Magnitude of Potential Risk With the Administration of Primovist/Eovist in Patients With Moderate to Severe Renal Impairment for the Development of Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical and Histopathologic Information.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contrast Media
Keywords: Nephrogenic Systemic Fibrosis (NSF)
Primovist / Eovist
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-05-27
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to participate.

The administration of contrast agents that contain gadolinium such as Primovist/Eovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Primovist/Eovist.

Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.

Detailed description: Adverse events data will be reported in Adverse Events section.

Eligibility criteria: Inclusion Criteria:

* Patient must be scheduled for Contrast enhanced magnetic resonance imaging (CE-MRI) of the liver with Primovist/Eovist based on careful risk/benefit evaluation at the recommended dose in one of the approved indications
* Patient must fulfill criteria for moderate (Estimated glomerular filtration rate \[eGFR\] 30 - 59 mL/min/1.73 m\^2) to severe (eGFR \< 30 mL/min/1.73 m\^2) renal impairment.

Exclusion Criteria:

* Gadolinium based contrast agent (GBCA)-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Primovist/Eovist within 12 months prior to administration of Primovist/Eovist
* History of existing NSF

Primary outcomes:
measure: Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information
timeFrame: Up to 24 months following the administration of Primovist/Eovist
Secondary outcomes:
measure: Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score
timeFrame: Up to 24 months following the administration of Primovist/Eovist
measure: Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)
timeFrame: Immediately after Primovist/Eovist-enhanced MRI
measure: Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Detection
timeFrame: Immediately after Primovist/Eovist-enhanced MRI
measure: Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Delineation
timeFrame: Immediately after Primovist/Eovist-enhanced MRI
measure: Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Characterization
timeFrame: Immediately after Primovist/Eovist-enhanced MRI
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Honolulu
country: United States
state: Hawaii
city: Topeka
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Ann Arbor
country: United States
state: Michigan
city: Brooklyn
country: United States
state: New York
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Memphis
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Herston
country: Australia
state: Queensland
city: Woollongabba
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Geelong
country: Australia
state: Victoria
city: Westmead NSW
country: Australia
city: Graz
country: Austria
city: Wien
country: Austria
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Stuttgart
country: Germany
state: Baden-Württemberg
city: Erlangen
country: Germany
state: Bayern
city: Frankfurt
country: Germany
state: Hessen
city: Marburg
country: Germany
state: Hessen
city: Hannover
country: Germany
state: Niedersachsen
city: Dortmund
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Dresden
country: Germany
state: Sachsen
city: Gera
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Rozzano
country: Italy
state: Milano
city: Pozzuoli
country: Italy
state: Napoli
city: Candiolo
country: Italy
state: Torino
city: Brescia
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Palermo
country: Italy
city: Pisa
country: Italy
city: Busan
country: Korea, Republic of
state: South Korea
city: Seoul
country: Korea, Republic of
state: South Korea
city: Seoul
country: Korea, Republic of
city: Granada
country: Spain
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Songkhla
country: Thailand
city: Bristol
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: