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

This study is currently recruiting participants.
Verified March 2014 by Shire
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01806545
First received: March 5, 2013
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Arteriovenous Fistula
Biological: SRM003
Other: Participating Site's standard practice
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Phase 2, Single-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy and Safety of SRM003 (Vascugel®) in Improving the Rate of Arteriovenous Fistula Maturation and Use in Subjects Undergoing Surgery for Creation of an Arteriovenous Fistula for Hemodialysis Access

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • To compare the time to arteriovenous fistula maturation for arteriovenous fistulas treated with SRM003 with those treated with participating sites' standard practice. [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare the overall duration of patency for AVFs treated with SRM003 with that for AVFs treated with participating sites' standard practice. [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 192
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SRM003
One time implant (2 SRM003 pieces) on surgery day. Post-surgery, up to 26 weeks follow-up for assessment of efficacy/safety.
Biological: SRM003
One time implant (2 SRM003 pieces) on surgery day.
Other Name: Allogeneic human aortic endothelial cells cultured in a gelatin matrix (Gelfoam®).
Participating Site's standard practice
Subjects will receive sites' standard practice treatment during the surgical procedure.
Other: Participating Site's standard practice
Subjects will receive sites' standard practice treatment during the surgical procedure.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Subject who is of child bearing potential must agree to use adequate contraception for 6 months after randomization.
  3. 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.
  4. Subject must have a life expectancy of at least 26 weeks after randomization.
  5. Subject must be able to understand and be willing to complete all study requirements.

Exclusion Criteria:

  1. 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.
  2. Subject has had more than 1 access placement surgery (defined as a new access, not a revision) in the target limb.
  3. Subject has medical conditions and diseases that may cause non-compliance with the protocol
  4. Subject has a known allergy to bovine/porcine products or collagen/gelatin products.
  5. Subject has a history of intravenous drug use within 6 months prior to screening
  6. Subject is morbidly obese, defined as having a body mass index >40.
  7. Pregnant or nursing woman, or plans to become pregnant during the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01806545

Contacts
Contact: Jack Van Loon 1 (858) 754-5720 jvanloon@shire.com

  Hide Study Locations
Locations
United States, Arizona
Akdhc Medical Research Services Recruiting
Phoenix, Arizona, United States, 85012
Contact: Erica Diaz, MA    602-527-0870    ediaz@akdhc.com   
Principal Investigator: Rick Mishler, MD         
Tucson Vascular Consultants Recruiting
Tucson, Arizona, United States, 85745
Contact: Megon Cundiff, BS    520-495-6971    megon.cundiff@carondelet.org   
Principal Investigator: Rhonda Quick, MD         
United States, California
Ladenheim Dialysis Access Center Recruiting
Fresno, California, United States, 93710
Contact: Jessica Weidenbach    559-446-1065    JWeidenbach@ladenheim.net   
Principal Investigator: Siddhartha Agrawal         
California Institute of Renal Research Recruiting
La Mesa, California, United States, 91942
Contact: Tania Rodriguez    619-461-3880    trodriguez@cairr.com   
Principal Investigator: George Fadda, MD         
VA Long Beach Health Care System Pharmacy Recruiting
Long Beach, California, United States, 90822
Contact: Penny Shafer    562-826-8000 ext 3921    Penny.shafer@va.gov   
Principal Investigator: Gaurang Shah, MD         
The Regents University of California Los Angeles Recruiting
Los Angeles, California, United States, 90025
Contact: Jason Norris    310-954-2692    jasonorris1@ucla.edu   
Principal Investigator: Anjay Rastogi, MD         
California Institute of Renal Research Recruiting
San Diego, California, United States, 92123
Contact: Zandra Wing    858-637-4600    zwing@cairr.com   
Principal Investigator: Steven Steinberg         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Chris Pau    415-353-4367    Chris.Pua@ucsfmedctr.org   
Principal Investigator: Michael Conte, MD         
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Birgit Bispham    303-724-7794    birgit.bispham@ucdenver.edu   
Principal Investigator: Michel Chonchol         
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520-8042
Contact: Siobahn Thompson    203-785-4184    siobhan.thompson@yale.edu   
Principal Investigator: John Aruny, MD         
United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Deborah Fernandez    813-844-5692    debbiefernandez@tgh.org   
Principal Investigator: Rajendra Baliga, MD         
United States, Georgia
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912
Contact: Peggy Best    706-721-9546    pbest@gru.edu   
Principal Investigator: John White, MD         
United States, Illinois
Illinois Kidney Disease & Hypertension Center Recruiting
Peoria, Illinois, United States, 61603
Contact: Becky Slawik    309-495-5331    bjs@renalcareassoc.com   
Principal Investigator: Samer Sader, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Rachael Anderson, CRC    502-852-2290    rnande03@louisville.edu   
Principal Investigator: Alfred Jacobs, MD         
United States, Louisiana
Ochsner Baptist Medical Center, Clinical Trials Unit Recruiting
New Orleans, Louisiana, United States, 70115
Contact: Paritosh Pandya    504-894-2818    ppandya@ochsner.org   
Principal Investigator: Efrain Reisin         
Louisiana State University Health Science Center Shreveport Recruiting
Shreveport, Louisiana, United States, 71130
Contact: Tommie Stapleton    318-675-8320    tstapl@lsuhsc.edu   
Principal Investigator: Kenneth Abreo, MD         
United States, Massachusetts
Baystate Medical Center Pharmacy Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Jerry Korona    413-794-8888    Gerald.korona@baystatehealth.org   
Principal Investigator: Michael Germain         
United States, Michigan
Renaissance Renal Research Institute, LLC Recruiting
Detroit, Michigan, United States, 48236
Contact: Lori McFadden    313-432-6263    lmcfadden@scsp.net   
Principal Investigator: Keith Bellovich         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Dana Hallal, MS    313-916-1931    DHALLAL1@hfhs.org   
Contact: Mohamed Zidan    313-916-7103    mzidan@hfhs.org   
Principal Investigator: Lalathaksha Kumbar, MD         
McLaren Northern Michigan Hospital-NISUS Research Recruiting
Petoskey, Michigan, United States, 49770
Contact: Colleen Shaw, RN    231-487-4374    cmshaw@northernhealth.org   
Principal Investigator: Gary Shaw, MD         
Providence Hospital, Research Dept. Recruiting
Southfield, Michigan, United States, 48075
Contact: Kathryn Telck, RN    248-849-3104    Kathryn.Telck@providence-stjohnhealth.org   
Principal Investigator: Kevin Nolan, MD         
United States, Missouri
Clinical Research Consultants, LLC Recruiting
Kansas City, Missouri, United States, 64111
Contact: Mary Parrigon    816-756-1222    mary@crckcmo.com   
Principal Investigator: Ahmed Awad         
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Kathy Dodds    314-362-5705    doddsk@wudosis.wustl.edu   
Principal Investigator: Surendra ShenoyMD         
United States, Nevada
Sierra Nevada Nephrology Consultants Recruiting
Reno, Nevada, United States, 89511
Contact: Jennifer Hurst    775-322-4550    jhurst@nevadakidney.com   
Principal Investigator: Michael Murphy, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Evan Lipsitz, MD    718-920-4108    lscher@montefiore.org   
Principal Investigator: Larry Scher, MD         
United Health Services Recruiting
Johnson City, New York, United States, 13790
Contact: Martha Nelson, MS    607-763-5697    martha_nelson@uhs.org   
Principal Investigator: Mohammad Quasem, MD         
Mount Sinai School of Medicine Lab Recruiting
New York, New York, United States, 10029
Contact: Johanna Lou    212-241-8250    johanna.lou@mountsinai.org   
Principal Investigator: Vijay Lapsia, MD         
United States, North Carolina
Metrolina Nephrology Associates, PA Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Sandra DuPree    704-348-2992 ext 6877    sdupree@metrolinanephrology.com   
Principal Investigator: Verachai Lohavichan, MD         
ECU Department of Nephrology and Hypertension Recruiting
Greenville, North Carolina, United States, 27834
Contact: Winifred Bryant    252-744-2577    BRYANTW@ecu.edu   
Principal Investigator: Cynthia Christiano         
United States, North Dakota
Sanford Research/USD-Fargo Recruiting
Fargo, North Dakota, United States, 58122
Contact: Corliss Miller    701-234-3722    corliss.miller@sanfordhealth.org   
Principal Investigator: Adit Mahale, MD         
United States, Ohio
University of Cincinnati Physicians Company Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Amy Pflum, RD    513-558-8310    amy.pflum@uc.edu   
Principal Investigator: Prabir Roy-Chaudhury, MD         
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Kimberly Mackay    216-444-4650    mackayk@ccf.org   
Principal Investigator: Richard Fatica, MD         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Mindy Bowers    614-293-5505    Mindy.bowers@osumc.edu   
Principal Investigator: Anil Agarwal, MD         
Toledo Hospital Recruiting
Toledo, Ohio, United States, 43560
Contact: Lani Brighton    419-291-2373    lani.brighton@promedica.org   
Principal Investigator: Ken Lempert         
United States, Oregon
Kaiser Permanente Northwest Recruiting
Milwaukie, Oregon, United States, 97267
Contact: Amy Ronfeld    503-786-1600    Micah.L.Thorp@kpchr.org   
Principal Investigator: Micah Thorp, MD         
Northwest Renal Clinic, Inc. Recruiting
Portland, Oregon, United States, 97210
Contact: Jerimi Boston    503-229-7976    jboston@nwrc.com   
Principal Investigator: Michael Walczyk, MD         
United States, Pennsylvania
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Traci Eicherberger, RN    610-402-1286    Traci_L.Eichelberger@lvhn.org   
Contact: Lauren Hoover    610-402-1735    Lauren_K.Hoover@lvhn.org   
Principal Investigator: Michael Moritz, MD         
Temple University School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Zoe Pfeffer    215-707-4712    zoe.pfeffer@tuhs.temple.edu   
Principal Investigator: Crystal Gadegbeku, MD         
Delaware Valley Nephrology and Hypertension Associates, PC Recruiting
Philadelphia, Pennsylvania, United States, 19118
Contact: Lynne Parker    267-437-3163    parkerly@comcast.net   
Principal Investigator: Edward Jones         
Penn Medicine, Perelman Center for Advanced Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Debra Grier (AVG)    215-615-4938    Debbra.Grier@uphs.upenn.edu   
Contact: Robin Neubauer (AVF)    215-615-0773    robin.neubauer@uphs.upenn.edu   
Principal Investigator: Yonghong Huan         
United States, South Carolina
SC Nephrology & Hypertension Center, Inc. Recruiting
Orangeberg, South Carolina, United States, 29118
Contact: Sarah Wannamaker    803-531-2220    sarahjane@scnephrology.net   
Principal Investigator: Moustafa Moustafa         
United States, Tennessee
Erlanger Hospital Pharmacy Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Dennis Buckelew    423-778-6340    dennis.buckelew@erlanger.org   
Principal Investigator: Claude Galphin         
Nephrology Associates, P.C. Recruiting
Nashville, Tennessee, United States, 37205
Contact: Shinieka Wilson, RN         
Principal Investigator: Douglas Linfert, MD         
United States, Texas
Baylor College of Medicine ICTR Recruiting
Houston, Texas, United States, 77030
Contact: Wren Pratt    713-798-2157    wlpratt@bcm.edu   
Principal Investigator: Sreedhar Mandayam         
United States, Vermont
Fletcher Allen Health Care Renal Service Recruiting
Burlington, Vermont, United States, 05401
Contact: Cindy Wolkin, BSN    802-656-3607    cindy.wolkin@vtmednet.org   
Principal Investigator: Jeffrey Rimmer, MD         
United States, Virginia
Sentara Vascular Specialists Recruiting
Norfolk, Virginia, United States, 23507
Contact: Janice Devlin Devlin    757-622-2649    jldevlin@sentara.com   
Principal Investigator: Marc Glickman         
United States, Washington
Wenatchee Valley Medical Center Recruiting
Wenatchee, Washington, United States, 98801
Contact: Jennifer Gault    509-665-5800    jgault@wvmedical.com   
Principal Investigator: Joseph Anzalone, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Andrea Maser    608-265-6544    alm@clinicaltrials.wisc.edu   
Principal Investigator: Micah Chan, MD         
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Steven Steinberg California Institute of Renal Research
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01806545     History of Changes
Other Study ID Numbers: AVF01-SRM003
Study First Received: March 5, 2013
Last Updated: March 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
Arteriovenous Fistula Surgery
Vascular Injury
Hemodialysis Access

Additional relevant MeSH terms:
Arteriovenous Fistula
Fistula
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014