Treatment of Patients With Nephrogenic Systemic Fibrosis With Glivec
NSF
An Open Label Clinical Trial of Imatinib Mesylate(Glivec)in Patients With Moderate to Severe Nephrogenic Systemic Fibrosis
1 other identifier
interventional
10
1 country
2
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 treatment options of NSF. Various treatments have been tried to stop the progressing disease. Corticosteroids, which suppress the early inflammatory stage of the disease, fail to halt disease progression. Other immunosuppressive agents, photopheresis, and kidney transplantations are reported to be partly beneficial to the patients. It has not been possible to confirm these findings in further studies because in photopheresis, and kidney transplantation, such effects are generally unreproducible.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2009
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 21, 2009
CompletedFirst Posted
Study publicly available on registry
September 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJune 5, 2012
June 1, 2012
1.2 years
September 21, 2009
June 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoints are skin fibrosis and joint mobility.
16 weeks or 28 weeks
Secondary Outcomes (1)
The secondary endpoint is and joint mobility.
16 weeks or 28 weeks
Interventions
400 mg, one tablet daily for 12 or 24 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Dermatology
Aarhus, Aarhus, 8000, Denmark
Department of Dermatology
Aarhus, 8000, Denmark
Related Publications (1)
Kay J, High WA. Imatinib mesylate treatment of nephrogenic systemic fibrosis. Arthritis Rheum. 2008 Aug;58(8):2543-8. doi: 10.1002/art.23696.
PMID: 18668587BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne B Olesen, MD,PhD
Anne Braae Olesen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2009
First Posted
September 22, 2009
Study Start
September 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
June 5, 2012
Record last verified: 2012-06