Overview

Treatment of Patients With Nephrogenic Systemic Fibrosis With Glivec

Status:
Completed

Trial end date:
2010-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Aarhus

Treatments:

Imatinib Mesylate

Criteria

Inclusion criteria:

1. Age > 18 years

2. Diagnosed with NSF

3. mRodnan skin score => 20 or

4. Rapid progression of the disease defined as a 50% increase in mRodnan skin score in
less than 7 weeks or

5. Progression of the fibrosis in the inner organs ex. the heart or the lungs, AND

6. No absolute contraindications to the treatment

Exclusion Criteria:

1. Known sensitivity to Imatinib mesylate or to any of its components

2. Pregnant or lactating woman

3. ALAT > 3 x upper limit of normal

4. Severe congestive heart failure (NYHA Class III or IV)