Clinical Trial Details
| Trial ID: | L1664 |
| Source ID: | NCT05425056 |
| Associated Drug: | Sirolimus |
| Title: | A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery |
| Acronym: | ACCESS2 |
| Status: | ACTIVE_NOT_RECRUITING |
| Study Results: | NO |
| Results: | |
| Conditions: | Complication of Renal Dialysis|End Stage Renal Disease|End Stage Kidney Disease|ESRD|Chronic Kidney Failure|Complication of Hemodialysis|Vascular Access Complication|Arteriovenous Fistula |
| Interventions: | DRUG: Sirolimus |
| Outcome Measures: | Primary: 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 \[defined as the interval from access placement to the first session that the fistula can be cannulated with 2 needles (contributing to the FM definition)\]., 6 Months | |
| Sponsor/Collaborators: | Sponsor: Vascular Therapies, Inc. |
| Gender: | ALL |
| Age: | OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 136 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION |
| Start Date: | 2022-08-26 |
| Completion Date: | 2025-08 |
| Results First Posted: | |
| Last Update Posted: | 2024-08-09 |
| Locations: | Veterans Affairs San Diego Health Center, San Diego, California, 92161, United States|Lundquist Institute for Biomedical Innovation, Torrance, California, 90502, United States|MedStar Cardiovascular Research Network at MedStar Washington Hospital Center, Washington, District of Columbia, 20010, United States|American Access Care of Miami, Miami, Florida, 33156, United States|Emory University Hospital Midtown, Atlanta, Georgia, 30308, United States|Augusta University, Augusta, Georgia, 30912, United States|University of Louisville, Louisville, Kentucky, 40202, United States|The Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States|Mount Sinai Hospital, New York, New York, 10029, United States|Atrium Health, Charlotte, North Carolina, 28204, United States|Surgical Specialists of Charlotte, Charlotte, North Carolina, 28207, United States|The Regional Medical Center/Dialysis Access Institute, Orangeburg, South Carolina, 29118, United States|James Eric Gardner, MD PC, Memphis, Tennessee, 38115, United States|Arteries & Veins, El Paso, Texas, 79912, United States|Houston Methodist, Houston, Texas, 77030, United States|Houston Methodist, Sugar Land, Texas, 77479, United States|Sentara Norfolk General Hospital/Sentara Health Research Center, Norfolk, Virginia, 23507, United States|University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom|St Helier Hospital, Carshalton, SM5 1AA, United Kingdom|NHS Greater Glasgow and Clyde, Glasgow, United Kingdom|Barts Health NHS Trust of Royal London Hospital, London, United Kingdom|St George's University Hospitals NHS Foundation Trust, London, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT05425056 |
