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mTOR inhibitor

Sirogen for Arteriovenous Fistula Outcomes (ACCESS2 Trial)

Phase 3
Waitlist Available
Research Sponsored by Vascular Therapies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Successful creation of a single stage radiocephalic end to side fistula
Age 65 years or older
Must not have
Prior AV access created on the limb where the fistula surgery is planned
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether a prophylactic treatment delivered during surgery can improve long-term outcomes for people needing hemodialysis.

Who is the study for?
This trial is for people aged 65 or older who have been on hemodialysis for less than a year and are getting a new arteriovenous fistula. It's not for those with previous AV access in the same limb, planned peritoneal dialysis soon, sirolimus or bovine collagen allergies, HIV positive individuals, prisoners, or substance abusers.
What is being tested?
The study tests Sirogen—a Sirolimus eluting Collagen implant—given once during surgery to create an arteriovenous fistula used in hemodialysis. The goal is to see if this treatment can prevent complications related to vascular access.
What are the potential side effects?
Potential side effects of Sirogen may include local reactions at the surgery site due to sirolimus or collagen components such as pain, swelling, infection risk increase and possibly allergic reactions in those sensitive to the ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had a successful single stage radiocephalic fistula surgery.
Select...
I am 65 years old or older.
Select...
I have been on hemodialysis for 12 months or less.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a previous surgery for vein access in the same arm where my fistula surgery is planned.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pathologic fistula

Side effects data

From 2008 Phase 4 trial • 293 Patients • NCT00118742
29%
Diarrhoea
18%
Abdominal Pain
16%
Nausea
16%
Headache
16%
Fatigue
16%
Hepatitis C
14%
Vomiting
14%
Pyrexia
14%
Leukopenia
12%
Oedema Peripheral
11%
Insomnia
10%
Anaemia
10%
Hyperkalaemia
10%
Tremor
10%
Back Pain
10%
Hypertension
9%
Cough
9%
Pruritis
9%
Arthralgia
8%
Neutropenia
8%
Abdominal Pain Upper
8%
Dizziness
8%
Pain in Extremity
8%
Hepatic Enzyme Increased
7%
Dyspnoea
7%
Constipation
7%
Sinusitis
7%
Weight Decreased
6%
Blood Creatinine Increased
6%
Liver Function Test Abnormal
6%
White Blood Cell Count Decreased
5%
Muscle Spasms
5%
Decreased Appetite
5%
Jaundice
5%
Renal Failure
5%
Weight Increased
5%
Upper Respiratory Tract Infection
5%
Nasopharyngitis
5%
Asthenia
5%
Incision Site Pain
5%
Depression
4%
Anorexia
4%
Night Sweats
4%
Oropharyngeal Pain
4%
Rhinorrhoea
3%
Thrombocytopenia
3%
Hyperlipidaemia
3%
Pleural Effusion
3%
Myalgia
3%
Rash
3%
Acne
3%
Incisional Hernia
2%
Hypokalaemia
2%
Sepsis
2%
Pneumonia
1%
Hepatic Artery Stenosis
1%
Renal Failure Acute
1%
Cerebral Haemorrhage
1%
Urinary Retention
1%
Hypoglycaemia
1%
Encephalopathy
1%
Non-Small Cell Lung Cancer Metastatic
1%
Hypercholesterolaemia
1%
Multi-Organ Failure
1%
Crohn's Disease
1%
Chest Pain
1%
Blood Alkaline Phosphatase Increased
1%
Inappropriate Antidiuretic Hormone Secretion
1%
Ventricular Tachycardia
1%
Febrile Neutropenia
1%
Abdominal Hernia
1%
Transplant Rejection
1%
Clostridium Difficile Colitis
1%
Confusional State
1%
Benign Prostatic Hyperplasia
1%
Epstein-Barr Virus Associated Lymphoproliferative Disorder
1%
Hepatic Failure
1%
Portal Vein Thrombosis
1%
Cardiac Failure Congestive
1%
Atrial Flutter
1%
Gastritis
1%
Gastrointestinal Tract Adenoma
1%
Hepatic Neoplasm Malignant
1%
Blood Glucose Increased
1%
Gastrointestinal Haemorrhage
1%
Spinal Osteoarthritis
1%
Convulsion
1%
Peritonitis
1%
Haemorrhage Intracranial
1%
Deep Vein Thrombosis
1%
Inguinal Hernia
1%
Viral Infection
1%
Acarodermatitis
1%
Atrial Fibrillation
1%
Malaise
1%
Hepatic Cancer Metastatic
1%
Adenocarcinoma
1%
B-Cell Lymphoma
1%
Desmoid Tumour
1%
Pulmonary Embolism
1%
Stomatitis
1%
Influenza
1%
Staphylococcal Infection
1%
Umbilical Hernia
1%
Hepatic Function Abnormal
1%
Hyponatraemia
1%
Bacteraemia
1%
Cellulitis
1%
Clostridial Infection
1%
Diverticulitis
1%
Escherichia Urinary Tract Infection
1%
Lactobacillus Infection
1%
Lobar Pneumonia
1%
Pseudomonal Sepsis
1%
Post Procedural Haemorrhage
1%
Procedural Pain
1%
Biliary Anastomosis Complication
1%
Complications of Transplanted Kidney
1%
Bile Duct Obstruction
1%
Bile Duct Stenosis
1%
Biliary Tract Disorder
1%
Autoimmune Hepatitis
1%
Cholestasis
1%
Lung Disorder
1%
Pulmonary Oedema
1%
Sinus Congestion
1%
Embolism Venous
1%
Orthostatic Hypotension
1%
Vasculitis
1%
Hyperglycaemia
1%
Graft Versus Host Disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
CellCept + CNI (Tacrolimus or Cyclosporine)
CellCept + Sirolimus

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment ArmExperimental Treatment1 Intervention
Subjects randomized to the treatment arm will undergo AV fistula surgery and will receive the Sirolimus eluting Collagen Implant (SeCI).
Group II: Control ArmActive Control1 Intervention
Subjects randomized to the control arm will undergo AV fistula surgery alone and will not receive an implant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
FDA approved

Find a Location

Who is running the clinical trial?

Vascular Therapies, Inc.Lead Sponsor
1 Previous Clinical Trials
269 Total Patients Enrolled
1 Trials studying Complication of Hemodialysis
269 Patients Enrolled for Complication of Hemodialysis
Sriram Iyer, MDStudy DirectorVascular Therapies, Inc.
3 Previous Clinical Trials
1,116 Total Patients Enrolled
1 Trials studying Complication of Hemodialysis
269 Patients Enrolled for Complication of Hemodialysis

Media Library

Sirolimus (mTOR inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05425056 — Phase 3
Complication of Hemodialysis Research Study Groups: Control Arm, Treatment Arm
Complication of Hemodialysis Clinical Trial 2023: Sirolimus Highlights & Side Effects. Trial Name: NCT05425056 — Phase 3
Sirolimus (mTOR inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05425056 — Phase 3
~5 spots leftby Mar 2025
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