At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 12 enrolled
Drug / intervention
Imatinib mesylatedrug
Likely dose
Imatinib mesylate 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Phase 2 Pilot Study to Determine the Safety, Efficacy and Tolerability of Gleevec (Imatinib Mesylate) in the Treatment of Nephrogenic Systemic Fibrosis
In Brief
A Phase 2 clinical trial evaluating Imatinib mesylate for Nephrogenic Systemic Fibrosis. Completed, enrolled 12 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNephrogenic Systemic Fibrosis
CountriesUnited States
CollaboratorsNovartis Pharmaceuticals
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedMay 2008
Primary CompletionJul 2009
TodayJul 2026
First PostedMay 13, 2008
Enrollment StartDec 1, 2007
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.1 years ago
Interventions
Imatinib mesylatedrug
400 mg p.o. daily for 4 months. Dosage was reduced to 200 mg if participants develop gastrointestinal intolerance or alopecia.