Clinical Trial for ANCA-Associated Vasculitis – Now Enrolling Patients

Clinical Trial for ANCA-Associated Vasculitis - Now Enrolling Patients

Sites throughout the U.S. and Canada are seeking patients with newly diagnosed or relapsed anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.  This clinical trial is designed to determine whether a new non-steroidal treatment, when added to standard of care treatment can improve the remission rate, kidney function, and/or improve vasculitis symptoms.  All patients will receive standard treatment with cyclophosphamide or rituximab and prednisone with a tapering dosage regimen.

The treatment, CCX168, blocks the complement 5a receptor, or C5aR, and has shown promising results in an animal model of ANCA-associated vasculitis, as well as a clinical trial conducted in Europe.  The clinical development program is now expanding into the U.S. and Canada.

Eligible patients must be 18 years of age or older with active granulomatosis with polyangiitis (Wegener’s granulomatosis), microscopic polyangiitis, or renal limited vasculitis.  Participants will be randomized to receive either CCX168 at one of two dose regimens plus rituximab or cyclophosphamide therapy, or placebo with rituximab or cyclophosphamide therapy.

All patients will receive oral prednisone at a tapering dose regimen.  Following the treatment period of 84 days, patients will continue to be followed for an additional 84 days while continuing to receive standard of care.  Approximately 14 study visits will be required.  Compensation for out-of-pocket travel or other study-related expenses is available for participating patients.

If you believe you are eligible for this study and may wish to participate, please contact one of the sites listed below.

Recruiting Centers:

Altoona Center for Clinical Research – Dr. Alan Kivitz
Duncansville, Pennsylvania
Contact Tracy Madonna or 814.693.0300, ext. 147

Sierra Nevada Nephrology Consultants – Dr. Soni Dhanireddy
Reno, Nevada
Contact Jennifer Hurst or 775.322.4550

The Seattle Arthritis Clinic – Dr. Richard Jimenez
Seattle, Washington
Contact Laura Vinson or 206.368.6123

University of North Carolina Hospitals – Dr. Patrick Nachman
Chapel Hill, North Carolina
Contact Anne Froment or 919. 445.2622

Southeast Renal Research Institute – Dr. James Tumlin
Chattanooga, Tennessee
Contact Brett Jennings or 423.826.8003

Lovelace Scientific Resources – Dr. Kevin Osgood
Austin, Texas
Contact Steven Burch or 512.901.8860

Low Country Rheumatology – Dr. Jennifer Murphy
Charleston, South Carolina
Contact Nicole Shoop or 843.572.1818

Arizona Arthritis & Rheumatology Research, PLLC – Dr. Areena Swarup
Mesa, Arizona
Contact Yelena Misaljevic or 480.626.6653

Ocean Blue Medical Research Center – Dr. Antonio Terrelonge
Miami Springs, Florida
Contact Yelamis Cartaya or 305.885.8983

Amarillo Center for Clinical Research – Dr. Constantine Saadeh
Amarillo, Texas
Contact Pamela Grant or 806.352.2453

Eastern Nephrology Associates-New Bern – Dr. Manuel Montero
New Bern, North Carolina
Contact Morgan Moore or 252.633.9262, ext. 203

Ohio State University – Dr. Brad Rovin
Columbus, Ohio
Contact Melissa Murphy or 614.685.6651

Northwest Louisiana Nephrology – Dr. Marwan Kaskas
Shreveport, Louisiana
Contact Deanna Lee Ferrell or 318.220.9792

Kidney Wellness Institute – Dr. George Hon
Long Beach, California
Contact Tanya Ferguson or 562.595.8600

Rheumatology Associates of North Alabama, PC – Dr. William Shergy
Huntsville, Alabama
Contact Connie Dufour or 256.704.7098

Dartmouth Hitchcock Medical Center – Dr. William Rigby
Lebanon, New Hampshire
Contact Cheryl Carlson or 603.650.4717

North Shore University Hospital – Dr. Galina Marder
Great Neck, New York
Contact Michelle Kong-Rosario or 516.708.2557

Columbia University Medical Center – Dr. Andrew Bomback
New York City, New York
Contact Irma Orbe or 212.342.0838

University of Pennsylvania – Dr. Peter Merkel
Philadelphia, Pennsylvania
Contact Brian Rice or 215.614.4407

MedStar Georgetown University Hospital – Dr. Serban Dragoi
Washington, DC
Contact Stephanie Gubb or 202.444.1210

University of Kansas Medical Center – Dr. Mireille El Ters
Kansas City, Kansas
Contact Dawn Lockhart or 913.945.6196
Click here for the study information.

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Vasculitis Foundation

The Vasculitis Foundation is the international organization for patients with vasculitis, their families, friends and the health care professionals who care for them.