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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00981942
Other study ID # 22505 TRE
Secondary ID
Status Completed
Phase Phase 3
First received September 21, 2009
Last updated June 4, 2012
Start date September 2009
Est. completion date December 2010

Study information

Verified date June 2012
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Imatinib mesylate (Glivec)
400 mg, one tablet daily for 12 or 24 weeks

Locations

Country Name City State
Denmark Department of Dermatology Aarhus

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The primary endpoints are skin fibrosis and joint mobility. 16 weeks or 28 weeks No
Secondary The secondary endpoint is and joint mobility. 16 weeks or 28 weeks No
See also
  Status Clinical Trial Phase
Completed NCT01135316 - Prospective Evaluation of the Incidence of NSF in Patients With Kidney Disease Undergoing MR N/A
Active, not recruiting NCT00677092 - Pilot Study of Imatinib Mesylate to Treat Nephrogenic Systemic Fibrosis Phase 2
Completed NCT00869479 - Validation of a Questionnaire to Identify Signs and Symptoms of Nephrogenic Systemic Fibrosis N/A
Enrolling by invitation NCT01359345 - Nephrogenic Systemic Fibrosis With Gadollinum Phase 2/Phase 3
Withdrawn NCT00811863 - Evaluation of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Following OptiMARK Injection N/A
Terminated NCT01078987 - Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF) Phase 4
Completed NCT01014754 - Nephrogenic Systemic Fibrosis (NSF): Analysis of Tissue Gadolinium Levels N/A