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Reduction of Plasma Free VEGF-A Using Low-dose Bevacizumab in Hemodialysis Patients

End Stage Renal Disease Clinical Trial

Official title:
A Phase 0 Study to Evaluate the Pharmacokinetics of Low-dose Bevacizumab and Its Efficacy on Reducing Plasma Free Vascular Endothelial Growth Factor-A (VEGF-A) in Hemodialysis Patients

Clinical Trial Summary

The primary purpose of this pilot study is to assess the pharmacokinetic profile of low-dose bevacizumab and its effectiveness in reducing plasma free VEGF-A levels safely in hemodialysis patients. This information will be used to plan a phase 1 clinical trial evaluating bevacizumab's role in hemodialysis vascular access failure.

Clinical Trial Description

It has been found that hemodialysis arteriovenous fistula failure is partly mediated through a VEGF pathway. The administration of bevacizumab (a VEGF-A monoclonal antibody) in arteriovenous fistula (AVF) murine models at a dose of 5mg/kg (a standard chemotherapeutic dose) has shown a significant reduction in stenosis formation and an overall improvement in vascular remolding. However, previous pharmacokinetic human studies have shown that bevacizumab administered at a low dose of 1.25mg intravitreally (ocular neovascularization patients) is sufficient enough to suppress circulating VEGF-A levels up to 30 days post administration. A chart review on 14 hemodialysis patients receiving an arteriovenous access and intravitreal bevacizumab has demonstrated a significant improvement in patency (HR: 0.45, p-value: 0.037) when compared to controls. Prior to a phase 1 trial, it is essential to determine if intravenous administration of bevacizumab demonstrates the same pharmacokinetics and bio-response profile as intravitreal administration, and to determine the optimal dose and frequency. This phase 0 study will be conducted in 10 existing hemodialysis patients at a dose of 1.25mg with a potential dose escalation to 2.5mg if optimal results are not seen. The findings from this study can have a substantial clinical impact not only in ESRD patients but also in patients receiving other vascular or endovascular procedures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02695641
Study type Interventional
Source Mayo Clinic
Contact
Status Withdrawn
Phase Early Phase 1
Start date August 1, 2019
Completion date November 2021
View Details
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