Status:
COMPLETED
Treatment of Patients With Nephrogenic Systemic Fibrosis With Glivec
Lead Sponsor:
University of Aarhus
Conditions:
Nephrogenic Systemic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The investigators will study the effect of imatinib mesylate (Glivec) in treatment of moderate to severe nephrogenic systemic fibrosis (NSF). So far there is no evidence of adequately effective treat...
Detailed Description
NSF is a relatively newly defined fibrosing disease not described before 1997 where the Gadolinium-based contrast agents (GBCAs) were introduced in patients with kidney disease. The association betwee...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age \> 18 years
- Diagnosed with NSF
- mRodnan skin score =\> 20 or
- Rapid progression of the disease defined as a 50% increase in mRodnan skin score in less than 7 weeks or
- Progression of the fibrosis in the inner organs ex. the heart or the lungs, AND
- No absolute contraindications to the treatment
- Exclusion Criteria:
- Known sensitivity to Imatinib mesylate or to any of its components
- Pregnant or lactating woman
- ALAT \> 3 x upper limit of normal
- Severe congestive heart failure (NYHA Class III or IV)
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00981942
Start Date
September 1 2009
End Date
December 1 2010
Last Update
June 5 2012
Active Locations (2)
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1
Department of Dermatology
Aarhus, Aarhus, Denmark, 8000
2
Department of Dermatology
Aarhus, Denmark, 8000