Clinical trial NCT00744939: Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist
Official title: Prospective Non-randomized Observational (Pharmacoepidemiologic) Cohort Study (Open-label, Multicenter) to Assess the Magnitude of Potential Risk With the Administration of Magnevist® Injection in Patients With Moderate Renal Impairment for the Development of Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical and Histopathologic Information.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibrosis
Kidney Failure
Renal Insufficiency
Keywords: Gadolinium
NSF
Renal Impairment
chemically induced
adverse effects
Contrast Media
complications
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-09-01
Enrollment: 168
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who are scheduled to undergo CE-MRI with Magnevist and for which the inclusion and exclusion criteria are fulfilled are eligible for enrolment into the study.

Brief summary: Assess potential risk for NSF in subjects with renal impairment (moderate) post magnevist injection. Subjects will be screened within 48 hours of previously scheduled MRI, those meeting the enrollment criteria will be enrolled prior to MRI and followed for 2 years post MRI with visits occuring at 1yr and 2 yr timepoints, in addition follow-up phone calls conducted at 1, 3, 6 and 18 months to assess for skin changes suggestive of NSF.


Eligibility criteria: Inclusion Criteria:

* Patients must have moderate (eGFR 30-59 ml/min/1.73 m\^2) renal impairment and be scheduled for a contrast enhanced MRI with Magnevist Injection at the recommended dose of 0.1 mmol/kg.

Exclusion Criteria:

* Gadolinium Based Contrast Agent (other then Magnevist) enhanced MRI within 12 months prior to administration of Magnevist
* History of NSF
* Clinically unstable or age \<2 yrs

Primary outcomes:
measure: Number of Participants Who Developed Nephrogenic Systemic Fibrosis (NSF), Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Full Analysis Set
timeFrame: Up to 24 months following the administration of Magnevist
measure: Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-full Analysis Set
timeFrame: Up to 24 months following the administration of Magnevist
measure: Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Per Protocol Set
timeFrame: Up to 24 months following the administration of Magnevist
measure: Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-per Protocol Set
timeFrame: Up to 24 months following the administration of Magnevist
Secondary outcomes:
measure: Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Full Analysis Set
timeFrame: Up to 24 months following the administration of Magnevist
measure: Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-full Analysis Set
timeFrame: Up to 24 months following the administration of Magnevist
measure: Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Per Protocol Set
timeFrame: Up to 24 months following the administration of Magnevist
measure: Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-per Protocol Set
timeFrame: Up to 24 months following the administration of Magnevist
measure: Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Full Analysis Set
timeFrame: Up to 24 months following the administration of Magnevist
measure: Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-full Analysis Set
timeFrame: Up to 24 months following the administration of Magnevist
measure: Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Per Protocol Set
timeFrame: Up to 24 months following the administration of Magnevist
measure: Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-per Protocol Set
timeFrame: Up to 24 months following the administration of Magnevist
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Chula Vista
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Pueblo
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Jacksonville
country: United States
state: Florida
city: Honolulu
country: United States
state: Hawaii
city: Honolulu
country: United States
state: Hawaii
city: Topeka
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Brooklyn
country: United States
state: New York
city: New York
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Danville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: