Trial Condition(s):

Fibrosis, Kidney Failure, Renal Insufficiency

Risk of nephrogenic systemic fibrosis (NSF) in patients with moderate renal insufficiency after the administration of Magnevist

Bayer Identifier:

13256

ClinicalTrials.gov Identifier:

NCT00744939

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
168
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Cleveland, United States, 44195

Status
Completed
 
Locations

Investigative Site

Jacksonville, United States, 32209-6595

Status
Completed
 
Locations

Investigative Site

Pueblo, United States, 81008

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02114

Status
Completed
 
Locations

Investigative Site

Danville, United States, 17822-2001

Status
Completed
 
Locations

Investigative Site

Stony Brook, United States, 11790

Status
Completed
 
Locations

Investigative Site

Baltimore, United States, 21287

Status
Completed
 
Locations

Investigative Site

Tacoma, United States, 98321

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77030

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States, 19141

Status
Completed
 
Locations

Investigative Site

New Haven, United States, 06520--804

Status
Completed
 
Locations

Investigative Site

Philadelphia, United States, 19104

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02118

Status
Completed
 
Locations

Investigative Site

Honolulu, United States, 96859

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02215

Status
Completed
 
Locations

Investigative Site

San Antonio, United States, 78229

Status
Completed
 
Locations

Investigative Site

Honolulu, United States, 96813

Status
Completed
 
Locations

Investigative Site

Memphis, United States, 38104

Status
Completed
 
Locations

Investigative Site

Brooklyn, United States, 11219

Status
Completed
 

Trial Design