A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
- Conditions
- Complication of HemodialysisArteriovenous FistulaEnd Stage Kidney DiseaseESRDChronic Kidney FailureEnd Stage Renal DiseaseComplication of Renal DialysisVascular Access Complication
- Interventions
- Registration Number
- NCT05425056
- Lead Sponsor
- Vascular Therapies, Inc.
- Brief Summary
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an arteriovenous fistula for hemodialysis vascular access.
- Detailed Description
This is a Phase 3, multicenter, randomized, single-blind, controlled, study designed to evaluate the efficacy and safety of the use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects who are on hemodialysis and are undergoing surgical creation of an AV fistula in comparison to subjects who do not receive the implant.
Subjects of either gender, who are at least 65 years of age, undergoing hemodialysis, and require a new single stage radiocephalic end to side fistula will be eligible to participate in this study. Subjects who meet eligibility criteria and undergo successful AV fistula creation will be eligible for enrollment. The study plans to enroll approximately 120 subjects, randomized in a 1:1 ratio. Enrolled subjects will be followed for a period of one year from the time of their index surgical procedure.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- Age 65 years or older
- Currently on hemodialysis for ≤12 months
- Successful creation of a single stage radiocephalic end to side fistula
- Prior AV access created on the limb where the fistula surgery is planned
- Planned start of peritoneal dialysis within 6 months of randomization
- Known hypersensitivity to the following: sirolimus, beef or bovine collagen
- Known to be HIV positive
- Prisoner, mentally incompetent, and/or current alcohol or drug abuser
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Arm Sirolimus Subjects randomized to the treatment arm will undergo AV fistula surgery and will receive the Sirolimus eluting Collagen Implant (SeCI).
- Primary Outcome Measures
Name Time Method Clinical Fistula Maturation (FM) 6 Months Clinical Fistula Maturation (FM) is defined as a fistula that can be cannulated with 2-needles for at least 75% of the dialysis sessions, including 3 consecutive sessions with a mean Qb of 300 mL/min (unless the prescribed Qb is \<300 mL/min) performed during any continuous 30 day period that commences no later than 180 days after randomization.
The primary endpoint will be summarized as a time-to-event endpoint for the SeCI (Sirogen) and control groups by reporting the cumulative proportion of AVF that achieve FM over time \[defined as the interval from access placement to the first session that the fistula can be cannulated with 2 needles (contributing to the FM definition)\].
- Secondary Outcome Measures
Name Time Method Fistula Suitability for Dialysis at 12 months (FSD12) 1 year Fistula Suitability for Dialysis at 12 months (FSD12) defined as a fistula that can be used for dialysis using 2 needles for at least 75% of the dialysis sessions performed during a 30 day period that commences on day 330.
Secondary Patency (SP) 1 year Secondary Patency (SP) defined as the interval from the time of randomization until access abandonment.
Time To First Dialysis (TTFD) 1 year Time To First Dialysis (TTFD) defined as the interval from the time of randomization to the first of three consecutive dialysis sessions using 2 needles with a mean Qb of ≥300 mL/min (unless the prescribed Qb is \<300 mL/min).
Mature Fistula with Preserved Function at 12 Months (MFPF) 1 year Mature Fistula with Preserved Function at 12 Months (MFPF) defined as a fistula that can be cannulated with 2 needles for at least 75% of the dialysis sessions, including 3 consecutive sessions with a mean Qb of ≥300 mL/min (unless the prescribed Qb is \<300 mL/min) performed during any continuous 30-day period that commences no later than 180 days after randomization (i.e., fistula achieves FM) AND can be used for dialysis using 2-needles for at least 75% of the for the dialysis sessions performed during a 30-day period that commences on day 330 (FSD12).
Durable Fistula Maturation (DFM) 1 year Durable Fistula Maturation (DFM) defined as a fistula that can be cannulated with 2 needles for at least 75% of the dialysis sessions, including 3 consecutive sessions with a mean Qb of ≥300 mL/min performed during any continuous 30-day period that commences no later than 180 days after randomization (i.e., fistula achieves FM) AND can be used for dialysis using 2-needles with a mean Qb of ≥300 mL/min for the dialysis sessions performed during a 30-day period that commences on day 330.
Cumulative Fistula Use (CFU) 1 year Cumulative Fistula Use (CFU) defined as the number of dialysis sessions performed using the study fistula with 2 needles and a mean Qb of ≥300 mL/min. CFU is calculated from the time of fistula creation to the end of study period or upon reaching an intercurrent event (Fistula abandonment, Death, Transfer to PD or transplant) or is lost to follow up.
Cumulative Catheter Exposure (CCE) 1 year Cumulative Catheter Exposure (CCE) is defined as the number of days a hemodialysis central venous catheter (CVC) is in situ and the duration of CVC exposure is calculated from the day of fistula creation (i.e., day of randomization) to the end of study period or upon reaching an intercurrent event.
Trial Locations
- Locations (21)
Veterans Affairs San Diego Health Center
🇺🇸San Diego, California, United States
Lundquist Institute for Biomedical Innovation
🇺🇸Torrance, California, United States
MedStar Cardiovascular Research Network at MedStar Washington Hospital Center
🇺🇸Washington D.C., District of Columbia, United States
American Access Care of Miami
🇺🇸Miami, Florida, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Augusta University
🇺🇸Augusta, Georgia, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
The Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Atrium Health
🇺🇸Charlotte, North Carolina, United States
Scroll for more (11 remaining)Veterans Affairs San Diego Health Center🇺🇸San Diego, California, United States