Overview

Pilot Study of Imatinib Mesylate to Treat Nephrogenic Systemic Fibrosis

Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the efficacy of imatinib mesylate in reducing cutaneous thickening and tethering in patients with nephrogenic systemic fibrosis (NSF). The study will also work to assess the safety and tolerability of imatinib mesylate in patients with chronic kidney disease and NSF.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Massachusetts General Hospital
Collaborator:
Novartis Pharmaceuticals
Treatments:
Imatinib Mesylate
Criteria
Inclusion Criteria:

- Age > 18 years

- Biopsy-proven NSF

- Ability to give consent

Exclusion Criteria:

- Known sensitivity to imatinib mesylate or to any of its components

- Pregnant or lactating woman

- Bullous dermatologic disease

- Aspartate aminotransferase / alanine aminotransferase (AST/ALT) >3 x upper limit of
normal

- Severe congestive heart failure [New York Heart Association (NYHA) Class III or IV]

- Patients who have received Gleevec in the past 12 months