The Access 2 Trial
Research type
Research Study
Full title
A Phase 3, Prospective, Randomized, Multicenter, Single-blind, Controlled Study evaluating Arteriovenous fistula outcomes with and without a Perivascular Sirolimus-eluting Collagen Implant
IRAS ID
1005084
Contact name
Rakesh Raghubanshi
Contact email
Sponsor organisation
Vascular Therapies, Inc.
Eudract number
2021-006718-36
Clinicaltrials.gov Identifier
Research summary
Summary of Research
A fistula is made by joining together a vein and an artery in the arm, allowing blood from the artery to pass through the vein causing the vein to become stronger and larger. This makes the vein more suitable for the insertion of special needles that are required during hemodialysis. \nSometimes, in a fistula the vein narrows at the point where it is connected to the artery which slows down the blood flow from the artery to the vein and increases the chance that the fistula may not develop enough to be useful for hemodialysis. If this happens, the treatment options are another procedure to treat this narrowing, another surgery to create a new access or dialysis using a catheter.\nThe purpose of this study is to find out if the experimental drug, Sirolimus eluting Collagen Implant (also called the implant), is safe and effective in preventing or reducing the narrowing of the fistula where the implant is placed. The implant is an experimental drug because it has not been approved by the MHRA for this use. The implant contains a drug called sirolimus contained within a collagen membrane. Sirolimus has several actions:\n•\tSirolimus may be taken by patients who receive a kidney transplant, to prevent the body from rejecting the transplanted kidney\n•\tSirolimus is also used to coat stents. Stents are put in the blood vessels supplying blood to the heart during a procedure called angioplasty. Sirolimus works by reducing formation of tissue inside the stents.\nIn this study, once the implant is wrapped around the newly created fistula by the surgeon, sirolimus is released - it may reduce the narrowing in the vein, which in turn may allow the vein to enlarge (mature), and become usable for hemodialysis.\nThe Collagen Implant is absorbed after the drug is released.\nThis study will be randomised between no implant and the study implant and will be conducted at 3 UK sites. the study plans to enrol approx 120 subjects globally and subjects will be followed for approx 1 year.Summary of results
"Clinical Trial Summary for Patients and the Public
Study Number: VT-305
Sponsor: Vascular Therapies, Inc.What was the purpose of this study?
People who require hemodialysis (a treatment to clean the blood when kidneys fail) often need a minor surgery to create an ""arteriovenous fistula,"" or simply a fistula. To create a fistula, a surgeon connects a vein to an artery in the arm. This causes the vein to grow larger and stronger, allowing enough blood to flow through it for dialysis needles to be inserted safely. This process is called “maturation.” A common problem with fistulas is that the vein can become too narrow at the point where it connects to the artery. If the vein becomes too narrow, blood cannot flow fast enough. This prevents the fistula from maturing properly, meaning it cannot be used for dialysis.
Researchers wanted to test a new implant that contains a medicine called Sirogen to see if the medicine can lower the number of fistulas that fail maturation. The researchers compared Sirogen against regular surgery without the medicine. This helps researchers understand if the improvements are due to the medicine or not.Who took part in this study?
The study took place in 19 hospitals across the United Kingdom and the United States.
Number of participants: 136 adults took part in the study.
• Age: Participants were over the age of 65 years old.
• Gender: 44 women and 92 men.
• Condition: Diagnosed with End Stage Renal Disease (ESRD) and needing a new fistula for dialysis.What happened during the study?
The researchers compared two different approaches:The Treatment Group: These patients had the standard surgery to create the fistula, and the surgeon also placed the Sirogen implant around the vein during the operation.
The Control Group: These patients had the standard surgery to create the fistula, but did not receive the implant. This allows researchers to see if the implant makes a difference compared to normal care.
What were the results?
The main question researchers asked was: Did the medicine help the fistula become ready for dialysis (mature) faster or more reliably than surgery alone? Researchers looked at the number of patients whose fistula was ""mature"" (fully developed and ready to be used for dialysis) by Day 210 (approximately 7 months after surgery).
The findings:
The study showed that the results were very similar for both groups.
• Group A (Sirogen): 70.2% of patients had a mature fistula by Day 210.
• Group B (Standard Surgery): 64.5% of patients had a mature fistula by Day 210.
Conclusion:
There was no significant difference between the two groups. This means that, in this study, adding Sirogen did not significantly increase the chances of the fistula becoming usable compared to standard surgery alone.What were the side effects?
Like all medicines, Sirogen can cause side effects, although not everybody gets them. Most participants tolerated the treatment well.
Most common side effects (affecting more than 1 in 10 people):
• Vein narrowing
• Vein closure
Serious side effects:
Serious side effects were rare. 1 person (out of 68 taking Sirogen) had a skin infection. The patient was treated with medication.Comparison of side effects:
Group A – Sirogen
Total patients: 68
Patients with any side effect: 64 (94.1%)
Patients who stopped due to side effects: 0Group B – Standard Surgery
Total patients: 67
Patients with any side effect: 64 (95.5%)
Patients who stopped due to side effects: 0How has this study helped patients and researchers?
This study helped researchers answer the question of whether Sirogen helps fistulas mature better than standard surgery. The results showed that the medicine did not provide a significant benefit over standard surgery alone. The number of fistulas that successfully matured was very similar in both the group that received the medicine and the group that did not.
Even though the implant did not work as hoped, this study provided valuable medical information. The data collected helps researchers understand fistula healing better. This will help them design different studies in the future to find other ways to support patients with kidney disease.
We thank all the participants. This research would not have been possible without the patients who took part. Your participation has helped doctors understand the best way to care for people who need dialysis access.Where can I find more information?
This document is a summary and does not contain all the information from the study.
• Full Medical Title: A Phase 3, Prospective, Randomized, Multicenter, Single-blind, Controlled Study evaluating Arteriovenous fistula outcomes with and without a Perivascular Sirolimus eluting Collagen Implant.
• UK Clinical Trials Register: [https://clinicaltrials.gov/study/NCT05425056]
• Study Contact: rakesh@vasculartx.com"REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0483
Date of REC Opinion
16 Aug 2022
REC opinion
Further Information Favourable Opinion