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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
136
SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.
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
...and 12 more locations
Clinical Fistula Maturation (FM)
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 \[defined as the interval from access placement to the first session that the fistula can be cannulated with 2 needles (contributing to the FM definition)\].
Time frame: 6 Months
Fistula Suitability for Dialysis at 12 months (FSD12)
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.
Time frame: 1 year
Secondary Patency (SP)
Secondary Patency (SP) defined as the interval from the time of randomization until access abandonment.
Time frame: 1 year
Time To First Dialysis (TTFD)
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).
Time frame: 1 year
Mature Fistula with Preserved Function at 12 Months (MFPF)
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).
Time frame: 1 year
Durable Fistula Maturation (DFM)
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.
Time frame: 1 year
Cumulative Fistula Use (CFU)
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.
Time frame: 1 year
Cumulative Catheter Exposure (CCE)
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.
Time frame: 1 year
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