Trial record 7 of 2665 for:    "Kidney Failure"

Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00744939
First received: August 20, 2008
Last updated: December 2, 2013
Last verified: December 2013
  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.


Condition Intervention Phase
Fibrosis
Kidney Failure
Renal Insufficiency
Procedure: Lab sample drawn for serum chemistry at baseline visit
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of subjects with onset of biopsy confirmed NSF or cutaneous skin changes consistent with NSF following the administration of Magnevist within the 2 year follow-up period [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Describe potential co-factors or risk modulators for the development of biopsy confirmed NSF or cutaneous skin changes consistent with NSF, including degree of disease, time of onset, clinical course, inflammatory events, vascular injuries, etc. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Serum creatinine must be obtained within 6 weeks of the administration of Magnevist, or as currently recommended by the American College of Radiology. At the Baseline within 48 hrs. pre-injection a chemistry panel will be obtained in all patients after intravenous access has been obtained.


Enrollment: 78
Study Start Date: November 2008
Study Completion Date: November 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm 1 Procedure: Lab sample drawn for serum chemistry at baseline visit
Patients will be followed for 2 years after the administration of Magnevist at the approved dose to see if symptoms consistent with NSF develop

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Patients must have moderate (eGFR 30-59 ml/min/1.73 m²) 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744939

  Show 26 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00744939     History of Changes
Other Study ID Numbers: 13256, X312141
Study First Received: August 20, 2008
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Gadolinium
NSF
Renal Impairment
chemically induced
adverse effects
Contrast Media
complications

Additional relevant MeSH terms:
Renal Insufficiency
Fibrosis
Nephrogenic Fibrosing Dermopathy
Pathologic Processes
Kidney Diseases
Urologic Diseases
Skin Diseases
Gadolinium DTPA
Gadobenic acid
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014