check_circleStudy Completed

Fibrosis, Kidney Failure, Renal Insufficiency

Bayer Identifier:

13256

ClinicalTrials.gov Identifier:

NCT00744939

EudraCT Number:

Not Available

EU CT Number:

Not Available
Risk of nephrogenic systemic fibrosis (NSF) in patients with moderate renal insufficiency after the administration of Magnevist

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.

Key Participants Requirements

Sex

Both

Age

2 Years
  • - 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.
  • - 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
November 2008 - November 2013
Phase
Phase 4
Could I Receive a placebo
No
Products
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Charlottesville, 22908, United States
Completed
Cleveland, 44195, United States
Completed
Jacksonville, 32209-6595, United States
Completed
Pueblo, 81008, United States
Completed
Boston, 02114, United States
Completed
Danville, 17822-2001, United States
Completed
Stony Brook, 11790, United States
Completed
Baltimore, 21287, United States
Withdrawn
Chula Vista, 91910, United States
Withdrawn
New York, 10016, United States
Completed
Tacoma, 98321, United States
Completed
Houston, 77030, United States
Completed
Philadelphia, 19141, United States
Withdrawn
Topeka, 66604, United States
Completed
New Haven, 06520--804, United States
Withdrawn
Santa Rosa, 95405, United States
Completed
Philadelphia, 19104, United States
Withdrawn
Los Angeles, 90033, United States
Completed
Boston, 02118, United States
Withdrawn
Phoenix, 85008, United States
Completed
Honolulu, 96859, United States
Completed
Boston, 02215, United States
Completed
San Antonio, 78229, United States
Completed
Honolulu, 96813, United States
Completed
Memphis, 38104, United States
Completed
Brooklyn, 11219, United States

Primary Outcome

  • Number of participants who developed nephrogenic systemic fibrosis (NSF), based on diagnostically specific clinical and histopathological information-cohort analysis and full analysis set
    date_rangeTime Frame:
    Up to 24 months following the administration of Magnevist
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants who developed NSF, based on diagnostically specific clinical and histopathological information-full analysis set
    date_rangeTime Frame:
    Up to 24 months following the administration of Magnevist
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants who developed NSF, based on diagnostically specific clinical and histopathological information-cohort analysis and per protocol set
    date_rangeTime Frame:
    Up to 24 months following the administration of Magnevist
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants who developed NSF, based on diagnostically specific clinical and histopathological information-per protocol set
    date_rangeTime Frame:
    Up to 24 months following the administration of Magnevist
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • 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
    date_rangeTime Frame:
    Up to 24 months following the administration of Magnevist
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    Up to 24 months following the administration of Magnevist
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    Up to 24 months following the administration of Magnevist
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    date_rangeTime Frame:
    Up to 24 months following the administration of Magnevist
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with adverse events (AEs) reported in association with the administration of Magnevist-cohort analysis and full analysis set
    date_rangeTime Frame:
    Up to 24 months following the administration of Magnevist
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with adverse events (AEs) reported in association with the administration of Magnevist-full analysis set
    date_rangeTime Frame:
    Up to 24 months following the administration of Magnevist
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with adverse events (AEs) reported in association with the administration of Magnevist-cohort analysis and per protocol set
    date_rangeTime Frame:
    Up to 24 months following the administration of Magnevist
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with adverse events (AEs) reported in association with the administration of Magnevist-per protocol set
    date_rangeTime Frame:
    Up to 24 months following the administration of Magnevist
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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.
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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