An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access

Completed · Phase 2

Conditions studied: Arteriovenous Fistula

In brief

A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis access. It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin matrix containing endothelial cells can provide a continuous supply of multiple growth regulatory compounds to the underlying cells within the blood vessel, while being protected from the effects of blood flow in the vessel(s) or complications resulting from being in direct contact with the point of injury.

Key facts

Study ID

NCT01806545

Run by

Shire

People needed

64

Starts

2013-03-26

Expected to finish

2014-10-27

Last updated by the study team

2021-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must be 18 years of age or older at the time of signing and dating informed consent (no upper age limit), can be male or female.
• Subject who is of child bearing potential must agree to use adequate contraception for 6 months after randomization.
• Subject must be currently undergoing hemodialysis or anticipating the start of hemodialysis and must require a new permanent, suitable access for the AVF creation in the upper extremity.
• Subject must have a life expectancy of at least 26 weeks after randomization.
• Subject must be able to understand and be willing to complete all study requirements.

You may not qualify if…

• Subject is currently on an active organ transplant list from a deceased donor or is undergoing assessment and expects to be placed on the active organ or bone marrow transplant list within the next 26 weeks from surgery, or expects to receive a living donor organ or bone marrow within the next 26 weeks and is unwilling to change transplant list status to "hold" for 3 months after randomization.
• Subject has had more than 1 access placement surgery (defined as a new access, not a revision) in the target limb.
• Subject has medical conditions and diseases that may cause non-compliance with the protocol
• Subject has a known allergy to bovine/porcine products or collagen/gelatin products.
• Subject has a history of intravenous drug use within 6 months prior to screening
• Subject is morbidly obese, defined as having a body mass index >40.
• Pregnant or nursing woman, or plans to become pregnant during the study.

Where it is running

• Akdhc Medical Research Services — Phoenix, Arizona, United States
• Tucson Vascular Consultants — Tucson, Arizona, United States
• Ladenheim Dialysis Access Center — Fresno, California, United States
• California Institute of Renal Research — La Mesa, California, United States
• VA Long Beach Health Care System Pharmacy — Long Beach, California, United States
• The Regents University of California Los Angeles — Los Angeles, California, United States
• California Institute of Renal Research — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Tampa General Hospital — Tampa, Florida, United States
• Georgia Regents University — Augusta, Georgia, United States
• Illinois Kidney Disease & Hypertension Center — Peoria, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• Ochsner Baptist Medical Center, Clinical Trials Unit — New Orleans, Louisiana, United States
• Louisiana State University Health Science Center Shreveport — Shreveport, Louisiana, United States
• Baystate Medical Center Pharmacy — Springfield, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Renaissance Renal Research Institute, LLC — Detroit, Michigan, United States
• McLaren Northern Michigan Hospital-NISUS Research — Petoskey, Michigan, United States
• Providence Hospital, Research Dept. — Southfield, Michigan, United States
• Clinical Research Consultants, LLC — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Sierra Nevada Nephrology Consultants — Reno, Nevada, United States
• United Health Services — Johnson City, New York, United States

Full record on ClinicalTrials.gov

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