drugset / Trial / NCT00878761

Study of STX-100 in Renal Transplant Patients With Interstitial Fibrosis and Tubular Atrophy (IF/TA)

NCT00878761 ↗

Phase 2 Withdrawn 48 enrolled Stromedix, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled, single followed by multiple dose, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and impact of STX-100 on gene and protein expression for αvβ6 related and TGF-β-inducible genes (including tubulointerstitial injury, epithelial function, and IF/TA related genes) in renal transplant patients with biopsy.

Timeline

Start
2010-09
Primary completion
2011-10
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject STX-100 Unknown 0.03 mg/kg Subcutaneous
Subject STX-100 Unknown 0.1 mg/kg Subcutaneous
Subject STX-100 Unknown 0.3 mg/kg Subcutaneous
Subject STX-100 Unknown 1 mg/kg Subcutaneous