NCT05425056 (ACCESS2) is a Phase 3 clinical trial of Sirolimus in Complication of Renal Dialysis, sponsored by Vascular Therapies, Inc..

Who is sponsoring NCT05425056?

NCT05425056 is sponsored by Vascular Therapies, Inc..

What drugs are being tested in NCT05425056?

Interventions in NCT05425056: Sirolimus.

What condition does NCT05425056 study?

NCT05425056 studies Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD, Chronic Kidney Failure, Complication of Hemodialysis, Vascular Access Complication, Arteriovenous Fistula.

Is NCT05425056 still recruiting?

NCT05425056 is currently completed. Last updated 24 September 2025.

Last reviewed 2025-09-24 · How we verify

NCT05425056: ACCESS2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery

Completed Phase 3 Last updated 24 September 2025

What this trial tests

Phase 3 trial testing Sirolimus in Complication of Renal Dialysis in 136 participants. Completed in 29 August 2025.

Timeline

26 August 2022

Primary endpoint
18 March 2025

29 August 2025

Quick facts

Lead sponsor	Vascular Therapies, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	136
Start date	26 August 2022
Primary completion	18 March 2025
Estimated completion	29 August 2025
Sites	22 locations across United Kingdom, United States

Drugs / interventions tested

Sirolimus (sirolimus) — full drug profile →

Conditions studied

Complication of Renal Dialysis — all drugs for Complication of Renal Dialysis →
End Stage Renal Disease — all drugs for End Stage Renal Disease →
End Stage Kidney Disease — all drugs for End Stage Kidney Disease →
ESRD — all drugs for ESRD →

Sponsor

Vascular Therapies, Inc.

Who can join

65 and older, any sex, with Complication of Renal Dialysis or End Stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Localized Perivascular Therapeutic Approaches to Inhibit Venous Neointimal Hyperplasia in Arteriovenous Fistula Access for Hemodialysis Use.
Barcena AJR, Perez JVD, Liu O, Mu A, et al · · 2022 · cited 21× · PMID 36291576 · DOI 10.3390/biom12101367
Cellular and molecular mechanisms underlying hemodialysis arteriovenous fistula dysfunction and approaches to promote maturation: a vascular perspective.
Shiu YT, Northrup H, Huang Y, Cho ME, et al · · 2025 · cited 7× · PMID 40465509 · DOI 10.1152/ajpheart.00010.2025
Human Data First: New Biological Premises for Arteriovenous Fistula Research.
Vazquez-Padron RI, Yu J, Tabbara M, Martinez L. · · 2026 · PMID 41641544 · DOI 10.1161/atvbaha.125.323428

Verify or expand the search:

Other trials of Sirolimus

Trials testing the same drug.

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NCT07052929 — Study of ASP2957 in Male Participants With X-linked Myotubular Myopathy Who Need Ventilators · Phase 1, PHASE2 · recruiting
NCT04370795 — Matched Related and Unrelated Donor Stem Cell Transplantation for Severe Combined Immune Deficiency (SCID): Busulfan-bas · Phase 1, PHASE2 · withdrawn
NCT07162038 — Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA- · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05425056 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vascular Therapies, Inc.
Last refreshed: 24 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05425056.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing