To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Humacyte, Inc.
Study ID
NCT05908084
Phase
PHASE3
Status
Recruiting
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Conditions

  • End Stage Renal Disease (ESRD)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acellular Tissue Engineered Vessel (ATEV) — BIOLOGICAL
    ATEV implantation
  • AVF — OTHER
    AVF creation procedure

Study Details

The goal of this clinical trial is to compare the number of catheter-free days (CFD) and the rate and severity of any dialysis access-related infections between the ATEV and AVF groups over 12 months in patients with end-stage renal disease (ESRD) needing hemodialysis (HD). Participants will be stratified by location of the vascular access (forearm versus upper arm) and by type of AVF creation procedure planned by the surgeon at randomization (1-stage AVF versus 2-stage AVF). The comparator is an upper extremity arterio-venous fistula (AVF) for HD access surgically created per the institution's Standard of Care (SoC).

Key Dates

Start date
Sep 7, 2023
Status verified
Mar 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ATEV treatment arm
    ATEV will be implanted as an arterio-venous (AV) access into the forearm or upper arm
  • Active Comparator: AVF treatment arm
    AVF creation procedure (1-stage AVF or 2-stage AVF) as an arterio-venous (AV) access into the forearm or upper arm

Primary Outcome Measure

The number of catheter-free days since randomization to Month 12. [ Time Frame: 12 months ]

Central Contacts

Locations (32)

FacilityCityStateZIPSite coordinators
Honor Health Scottsdale Shea Medical CenterScottsdaleArizona85260
Hasan Aldailami, MD
El Centro Regional Medical CenterEl CentroCalifornia92243
Luis Cajas-Monson, MD
Jacob's Medical Center at UC San Diego HealthLa JollaCalifornia92037
Mahmoud Malas, MD
Denver Health and Hospital AuthorityDenverColorado80204
Ernest Moore, MD
Yale New Haven HospitalNew HavenConnecticut06519
Cassius Chaar, MD
Access Research InstituteBrooksvilleFlorida34613
Lyle Breeding, MD
University of FL Health Heart and Vascular HospitalGainesvilleFlorida32608
Samir Shah, MD
Mayo Clinic FloridaJacksonvilleFlorida32224
Young Erben, MD
American Access Care of Miami, LLCMiamiFlorida33156
Jose Ramirez, MD
USF Health South TampaTampaFlorida33606
Aurelia Calero, MD
Georgia NephrologyAtlantaGeorgia30046
James Tumlin, MD
Grady Memorial HospitalAtlantaGeorgia30303
Manuel Garcia-Toca, MD
IU Health Bloomington HospitalBloomingtonIndiana47408
David Peterson, MD
John Hopkins University School of MedicineBaltimoreMaryland21287
Ying Wei Lum, MD
Boston Medical CenterBostonMassachusetts02118
Jeffrey Siracuse, MD
Brigham and Women's HospitalBostonMassachusetts02115
Mohamad Hussain, MD
University of MichiganAnn ArborMichigan48109
Karthik Ramani, MD
Rutgers University_MedicalNewarkNew Jersey07103
Michael Curi, MD
St.Joseph's University Medical CenterPatersonNew Jersey07503
John Danks, MD
Capital Health Medical Center- HopewellPenningtonNew Jersey08534
Jillian Walsh, MD
New York-Presbyterian Queens_The Lang Center for Research & EducationFlushingNew York11355
Sheng Kuo, MD
Ambulatory Care Pavilion Westchester Medical CenterValhallaNew York10595
Romeo Mateo, MD
Surgical Specialists of CharlotteCharlotteNorth Carolina28207
Jason Burgess, MD
Duke Regional HospitalDurhamNorth Carolina27704
Tristen Chun, MD
Wake Forest University School of Medicine_Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157
Justin Hurie, MD
Temple UniversityPhiladelphiaPennsylvania19140
Kenneth Chavin, MD
University of Tennessee Medical CenterKnoxvilleTennessee37920
Oscar Grandas, MD
Dell Seton Medical Center at The University of Texas at AustinAustinTexas78701
Pedro Teixeira, MD
Cataract & Surgery Center LubbockLubbockTexas79410
Ruben Villa, MD
Dr. Ruben Villa__NephrologyLubbockTexas79407-
San Antonio Vascular and Endovascular Clinic PLLCSan AntonioTexas78221-
The San Antonio Vascular and Endovascular ClinicSan AntonioTexas78221
Lyssa Ochoa, MD

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Honor Health Scottsdale Shea Medical Center· Scottsdale, AZEl Centro Regional Medical Center· El Centro, CAJacob's Medical Center at UC San Diego Health· La Jolla, CADenver Health and Hospital Authority· Denver, COYale New Haven Hospital· New Haven, CTAccess Research Institute· Brooksville, FL

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