NCT02495662

The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate if liposomal prednisolone is effective in promoting arteriovenous fistula (AVF) maturation when administered to human subjects after surgical creation of a radio-cephalic AVF.

Detailed description

AVFs are the preferred means of vascular access for maintenance hemodialysis. Nonmaturation occurs in 30-50% of cases, with highest rates in radio-cephalic fistulas. Inflammatory cytokines are involved in this process of nonmaturation. By suppressing inflammation, corticosteroids might promote maturation, but have significant systemic side effects. Liposomal prednisolone has a long circulation time and targets inflamed tissue with low systemic concentrations and limited side effects. In an animal study, it was demonstrated to promote AVF maturation. At present, no drug therapy aimed at improving shunt maturation is available. This study will investigate if liposomal prednisolone is effective in promoting AVF maturation when administered to human subjects after surgical creation of a radio-cephalic AVF.

Conditions

• Renal Dialysis
• Hemodynamics
• Vascular Remodeling
• Neointima

Interventions

Type	Name	Description
DRUG	PEG-liposomal prednisolone sodium phosphate	Liposomal prednisolone
DRUG	Placebo	0.9% normal saline

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-05-30
• Completion: 2018-05-30
• First posted: 2015-07-13
• Last updated: 2018-09-18

Locations

1 site across 1 country: Netherlands