Getting an AV fistula is an important step in your treatment journey. AV fistulas are the best access choice for hemodialysis according to the National Kidney Foundation. Sometimes, however, a fistula may develop a narrowing of the blood vessels, which restricts the blood flow needed for the vein to be suitable for hemodialysis.
In addition to being 65 years of age or older, you must also be currently on hemodialysis via a catheter, have been on hemodialysis for less than 12 months, and the planned AV fistula should be the first access in that arm.
You could help make a difference for future patients who require hemodialysis like you.
You may be reimbursed for visits over the course of the year-long study. Ask your doctor for details.
Sirogen™ is a bioabsorbable implant that delivers a well-known drug called sirolimus to blood vessels. Sirolimus has been shown to keep blood vessels open. It is used in kidney transplant patients and with vascular devices to reduce blood vessel narrowing. During surgery to create the fistula, Sirogen™ is applied at the area of the fistula that is prone to narrowing.
Sirogen™ has been studied in a previous Phase 2 clinical study and a Phase 3 randomized clinical study. In those studies, there were no safety concerns reported. In the Phase 3 study, Sirogen-treated patients had the same outcomes as patients without Sirogen™; however, in a post-hoc sub-group analysis patients aged 65 and older had improved results.
The objective of the ACCESS 2 clinical study is to see if the positive results from the first Phase 3 study can be reproduced in patients 65 and older.
The Phase 3 prospective randomized ACCESS 2 study will enroll 120 patients from centers in the U.S. and U.K. The study is being conducted to validate an encouraging subgroup analysis from the first Phase 3 (ACCESS) study that showed that Sirogen use in ESRD patients 65 years and older resulted in clinically meaningful improvement in AV fistula maturation and durability.
You must be at least 65 years of age and currently on hemodialysis for 12 months or less. You must have the first AV access in the arm where the fistula surgery is planned and have a successfully created single-stage radiocephalic end-to-side fistula. People with a history of steal syndrome or known hypersensitivity to sirolimus, beef, or bovine collagen cannot participate in the study. Additionally, you are not eligible to participate if you are currently in another clinical study. If you decide you would like to participate in the study, your doctor will determine if you meet the eligibility criteria. You will review and sign a patient consent form that explains the details of the study, including risks and potential benefits.