Status:
COMPLETED
Pilot Study of Imatinib Mesylate to Treat Nephrogenic Systemic Fibrosis
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Nephrogenic Systemic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 wor...
Detailed Description
Nephrogenic systemic fibrosis (NSF) is a recently described, extremely debilitating and painful condition that affects individuals with renal failure. Recent reports suggest an association between gad...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Biopsy-proven NSF
- Ability to give consent
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00677092
Start Date
December 1 2007
End Date
July 1 2009
Last Update
May 19 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114