This is a clinical study evaluating the effectiveness and safety of tesevatinib (an oral investigational drug) in patients with Autosomal Dominant PKD.
Before participating in the study, patients must complete a screening visit at one of the study centers. Eligible patients will be randomly assigned (like the flip of a coin) to receive either tesevatinib or placebo (an inactive capsule). The group of patients assigned to tesevatinib will be compared to the group of patients assigned to placebo in order to help researchers better understand the effects on PKD.
The investigational drug, study-related procedures and doctor visits will be provided at no cost. If you travel to the site for your study visits, travel expenses will be reimbursed and compensation for study-related time may be compensated.
You may be eligible for this study if you:
- Are between 18 to 60 years of age
- Have been diagnosed with ADPKD
- Have a lab value eGFR between 25 to 90 mL/min/1.73 m2
Exclusion Criteria:
- Previous nephrectomy or kidney transplant
- Subject is pregnant, plans to become pregnant, or nursing
- HIV positive
- Hepatitis B or C positive
- Immunocompromised
If you’re interested in participating, contact the Study Manager at:
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
Candy Leak
941-258-3556
candy.leak.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
410-706.2122
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
