Phase 2 N=12 Treatment

Pilot Study of Imatinib Mesylate to Treat Nephrogenic Systemic Fibrosis

Nephrogenic Systemic Fibrosis

Bottom Line

View on ClinicalTrials.gov: NCT00677092 ↗

Enrolled (actual)

Serious AEs

—

Results posted

May 2017

Primary outcome: Primary: Percentage Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Assess Skin Tethering — -24 percentage change in mRSS score

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Imatinib mesylate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Jul 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Assess Skin Tethering	-24	—
SECONDARY Change From Baseline in Maximal Extension of Elbows and Knees	—	—
SECONDARY Change From Baseline in Histologic Appearance of Skin Biopsy	—	—
SECONDARY Change From Baseline in Visual Analog Scale (VAS) for Pain	—	—
SECONDARY Change From Baseline in Health Assessment Questionnaire (HAQ) Score	—	—
SECONDARY Change From Baseline in Short Form 36 (SF-36) Score	—	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00677092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.