drugset / Trial / NCT00878761
Study of STX-100 in Renal Transplant Patients With Interstitial Fibrosis and Tubular Atrophy (IF/TA)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |