A Randomized Trial of Liposomal Prednisolone (LIPMAT) to Enhance Radiocephalic Fistula Maturation: A Pilot Study

Bram M Voorzaat,Josbert M Metselaar,Henk Boom,Karien Van Der Putten,Joris I Rotmans,Johannes O Groeneveld,Cornelis A Verburgh,Diederik Boon,Taisiya Bezhaeva,Ellen K Hoogeveen,Randolph G Statius Van Eps,Marcel C Weijmer,Jan Van Schaik,Liffert Vogt,Koen E.a Van Der Bogt ,B A Th F Gabreëls ,D Eefting ,L.c Huisman ,I.m Van Der Meer ,R.c Van Nieuwenhuizen

doi:10.1016/j.ekir.2020.05.030

Abstract

Patients on maintenance hemodialysis (HD) require a reliable vascular access; however, only half of newly created radiocephalic arteriovenous fistulas (RCAVF) can be used for HD without additional procedures to promote maturation and up 25% fail to provide adequate vascular access for HD.1 The need for subsequent creation of upper arm arteriovenous fistulas (AVFs) and arteriovenous grafts may decrease if maturation can be improved. Currently, no pharmacological treatments have been proven to improve clinical maturation of AVFs.

Highlights

In a murine model of arteriovenous fistulas (AVFs) failure, we have demonstrated that liposomal prednisolone inhibits inflammation of the juxta-anastomotic vein and improves outward remodeling of the venous outflow tract.[5]
In the Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation (LIPMAT) study, we aimed to assess if liposomal prednisolone improves maturation of radiocephalic arteriovenous fistulas (RCAVF) and if it can be safely administered to patients with endstage renal disease
From April 2016 through May 2018, 109 patients were planned for RCAVF creation and assessed for study eligibility

Summary

A Pilot Study

Pegylated liposomes have emerged as an attractive tool to facilitate selective delivery of drugs to inflamed tissues with a highly permeable microvasculature, where liposomes are being phagocytized by macrophages It has a potent and long-lasting anti-inflammatory effect at sites of inflammation, while minimizing exposure of noninflamed tissues. In the Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation (LIPMAT) study, we aimed to assess if liposomal prednisolone improves maturation of RCAVFs and if it can be safely administered to patients with endstage renal disease. The design of this multicenter randomized placebo-controlled trial has been reported earlier in detail,[6] and methods are available in the Supplementary Materials

RESULTS

DISCUSSION

CONCLUSION AND FURTHER DIRECTIONS