- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00981942
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 between NSF and GBCA has in many studies shown to be very strong. Until recently, radiologists believed that commercially available GBCAs were safe to use whether the renal function was normal or not. Since the 1980s, >200 million patients have been given these agents. Lately, the occurrence of NSF, a relatively new chronic disorder, has given serious speculations about the safety of these drugs and has questioned their future use. First identified in 1997, but not described until 2000, NSF has been reported only in patients with acute or chronic severe renal insufficiency (with a glomerular filtration rate <30 ml/min/1.73 m2).
Fibrosis in the subcutis means that the skin hardens and loses flexibility. Hard dermal plaque changes often appear on legs, arms and abdomen together with dyspigmentation. As the lesions involve the deep part of the subcutis the muscles are often affected. Involvement of the joints leads to contractures and narrowing of movement. Patients with massive affection of the joints often end up with a zimmer frame or in a wheelchair. The connecting tissue in the inner vital organs may also be affected and NSF can accelerate the death of the patient. The retained gadolinium in lesions of NSF can be found years after administration.
Interestingly, a case report suggests beneficial effects of imatinib mesylate in two patients. Two other independent case reports also show promising results.
Imatinib mesylate inhibits several tyrosine kinases involved in the fibrotic reaction, which is one of the main pathogenetic components of NSF.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Department of Dermatology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoints are skin fibrosis and joint mobility.
Time Frame: 16 weeks or 28 weeks
|
16 weeks or 28 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The secondary endpoint is and joint mobility.
Time Frame: 16 weeks or 28 weeks
|
16 weeks or 28 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne B Olesen, MD,PhD, Anne Braae Olesen
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22505 TRE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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