Phase 2
Completed N=12
Pilot Study of Imatinib Mesylate to Treat Nephrogenic Systemic Fibrosis
Nephrogenic Systemic Fibrosis
Source: ClinicalTrials.gov NCT00677092 ↗
Enrolled (actual)
12
Serious AEs
—
Results posted
May 2017
Primary outcomePrimary: Percentage Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Assess Skin Tethering — -24 percentage change in mRSS 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.
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 |
— | — |
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
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. Informational only — not medical advice.