An innovative, investigational treatment approach is showing the potential to address an important, unresolved problem encountered by patients with kidney failure on dialysis. At the recent annual meeting of the American Society of Nephrology (ASN), Vascular Therapies presented preliminary results relating to analysis of the first 18 (open-label) patients from its US phase III study. The study is testing the effect of the sirolimus-eluting collagen implant on arteriovenous fistula outcomes. The results suggest this investigational treatment approach may reduce a patient’s dependence on the extended use of catheters.
In the clinical trial, using Vascular Therapies’ proprietary system, surgeons deliver the drug sirolimus to the AV fistula at and around the regions where the vein and artery are surgically connected. The trial is testing whether this treatment approach will increase the proportion of fistulae that become suitable for dialysis use, thereby reducing the patient’s dependence on catheters.
Nationally, between 40% and 60% of AV fistulae are not suitable for dialysis. In the ongoing Vascular Therapies’ trial, 89% (16/18) of the AV fistulae in the open label patients were suitable for dialysis use at six months. Additionally, currently in the USA, dialysis patients remain on catheters for a median time of 111 days. In the open label patients, this wait time was reduced by about 40% to a median of 64 days.
“These encouraging outcomes from the 18 open label patients are consistent with what was seen in the 30-patient, single arm phase II study,” said Maria DeVita, senior nephrologist at Lenox Hill Hospital in New York, USA, and medical monitor for the study. “In the phase II study, the median time to first dialysis was 42 days and 76% of the fistulae were suitable for dialysis at six months.”
Nelson Kopyt, chief of Nephrology at Lehigh Valley Hospital in Allentown, USA, and a study investigator said, “Improving the proportion of fistulae that are suitable for dialysis and reducing catheter dwell times have remained frustratingly elusive goals. A positive trial and product approval will be transformational for haemodialysis vascular access management.”
Vascular Therapies is currently enrolling patients in its phase III randomised controlled study which is being performed under a Special Protocol Assessment (SPA). Topline results are expected in 2019.