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Tesevatinib in Subjects With ADPKD

The goal of the study is to compare and evaluate safety and efficacy of the drug tesevatinib in patients with ADPKD.

Intervention:
Drug: Tesevatinib

Drug: Placebo

Inclusion Criteria:

  • Diagnosis of ADPKD
  • eGFR between 25 – 90 mL/min/1.73 m2
  • Height adjusted total kidney volume:
    • ≥ 500 mL for individuals 18-35 years of age
    • ≥ 750 mL for 36-49 years of age
    • ≥ 900 mL for 50-60 years of age
  • Female subjects of childbearing potential with negative pregnancy test at screening
  • If sexually active, the subject agrees to use 2 accepted methods of contraception during the course of the study and for 6 months after their last dose of study drug

Exclusion Criteria:

  • Previous nephrectomy
  • Kidney transplant
  • Tuberous sclerosis
  • Hippel-Lindau disease
  • Acquired cystic disease
  • Moderate hematuria
  • Uncontrolled hypertension
  • Participated in other clinical trials within 30 days prior to first study visit
  • Received tolvaptan 30 days prior to first study visit
  • Received active treatment for urinary tract infection 4 weeks prior to first study visit
  • History of pancreatitis or known risk of pancreatitis
  • Has a cardiac pacemaker
  • History of pericardial effusion or presence of pericardial effusion on screening echocardiograph
  • Subject is pregnant, plans to become pregnant, or nursing
  • HIV positive
  • Hepatitis B or C positive
  • Immunocompromised
  • Documented renal vascular disease resulting in uncontrolled hypertension
  • Previously received an epithelial growth factor receptor (EGFR)
  • Allergy or hypersensitivity to components of tesevatinib or placebo or their formulations

Contact Information:

California
California Institute for Renal Research, La Mesa
Irish Lardizaball
619-461-3894
ilardizabal@cairr.com
Principal Investigator: George Fadda, MD

University of California Los Angeles
Farid Arman
310-825-7919
PKD@mednet.ucla.edu

University of California San Diego
La Jolla, California, United States, 92037
Jeff Ledford-Mills
619-786-2854
jhmills@ucsd.edu
Principal Investigator: Pranav Garimella, MD

University of California San Francisco
Julie Yeh
415-502-3618
chia-lin.yeh@ucsf.edu
Principal Investigator: Meyeon Park, MD

Colorado
University of Colorado Denver
Beverly Farmer
303-724-7790
beverly.farmer@ucdenver.edu
Principal Investigator: Michel Chonchol, MD

Connecticut
Yale Nephrology Clinical Research
Katrina Blount
203-737-1575
katrina.blount@yale.edu

Florida
Coastal Nephrology Associates Research Center, LLC
Beth Jackman
941-258-3556
bjack302@gmail.com
Heather Squires
941-258-3556
squires.heather.vmr@gmail.com
Principal Investigator: Kianoosh Kaveh, DO

Genesis Clinical Research
Cassie Miller
813-873-1016
cassiemiller@genesisclinicaltrials.com

Georgia
Emory University School of Medicine
Zohreh Forghani
404-712-1162
zohreh.forghani@emory.edu
Principal Investigator: Frederic Rahbari-Oskoui, MD

Illinois
University of Chicago
Sharon Trevino
773-702-6201
strevino@medicine.bsd.uchicago.edu 
Principal Investigator: Bharathi Reddy, MD

Maryland
University of Maryland
Charlett Diggs
410-328-0207
cdiggs@som.umaryland.edu
Principal Investigator: Steve Seliger, MD, MS

Massachusetts
Tufts Medical Center
Carly Tucker
617-636-7914
ctucker@tuftsmedicalcenter.org
Principal Investigator: Ronald Perrone, MD

Beth Israel Deaconess Medical Center
Shaelah Huntington
617-667-0317
shunting@bidmc.harvard.edu
Principal Investigator: Theodore I. Steinman, MD

Minnesota
Mayo Clinic
Lisa Bungum
507-266-4616
bungum.lisa2@mayo.edu

Missouri
Washington University, St. Louis
Sue Dombek
314-286-0819
dombeks@wustl.edu
Principal Investigator: Seth Goldberg, MD

New York
Rogosin Institute
Stephanie L. Donahue, NP.
212-746-1495
sld9001@nyp.org

Pennsylvania
University of Pennsylvania
Contact: Debbra Grier
215-615-4938
Debbra.Grier@uphs.upenn.edu

Texas
Baylor Scott & White Institute
Ashley Sauls, BS
254-935-5838
Ashley.Kossie@BSWHealth.org

Virginia
University of Virginia
Tracey Blount, RN MSN CCRC
434-924-1572
tdh4z@hscmail.mcc.virginia.edu
Principal Investigator: Mitchell Rosner, MD

Wisconsin
Medical College of Wisconsin
Ashley Schwarz
414-805-7208
aschwarz@mcw.edu
Principal Investigator: Ashraf El-Meanawy, MD