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