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Tesevatinib in Subjects With ADPKD

The goal of the study is to compare and evaluate safety and efficacy of tesevatinib 50mg versus placebo in patients with ADPKD.

Intervention:
Drug: Tesevatinib

Drug: Placebo

Inclusion Criteria:

  • ADPKD diagnosis based on Ravine’s criteria
  • Cysts of at least 1 cm
  • eGFR ≥ 30 mL/min/1.73 m2 and ≤ 80 mL/min/1.73 m2, using the Modification of Diet in Renal Disease-4 variable formula
  • htTKV ≥ 900 mL
  • The subject has the following laboratory values:

Platelets > lower limit of normal (LLN) Hemoglobin > 9 g/dL Total bilirubin ≤ 1.5 mg/dL Aspartate aminotransferase (AST) < 2.5 × upper limit of normal (ULN) Alanine aminotransferase (ALT) < 2.5 × ULN Prothrombin time/partial thromboplastin time ≤ 1.5 × ULN Serum potassium levels within normal limits Serum magnesium levels within normal limits Albumin ≥ LLN Amylase within normal limits Lipase within normal limits Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5, except those subjects taking warfarin who must have INR ≤ 3

  • 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
  • Congenital absence of 1 kidney and/or need for dialysis or transplantation in the foreseeable future
  • Moderate hematuria
  • Uncontrolled hypertension
  • Presence of renal or hepatic calculi (stones) causing symptoms
  • Received any investigational therapy within 30 days prior to initiation of therapy (Day 1 visit)
  • Received tolvaptan 30 days prior to initiation of therapy (Day 1 visit)
  • Received active treatment for urinary tract infection 4 weeks prior to initiation of therapy (Day 1 visit)
  • History of pancreatitis or known risk of pancreatitis
  • The subject meets any of the following cardiac criteria:
  • Mean QTc interval corrected for heart rate using Fridericia’s formula (QTcF) of > 450 msec
  • History of torsade de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (< 50 bpm), heart block (excluding first-degree block, being PR interval prolongation only), congenital long QT syndrome or new ST segment elevation or depression or new Q wave on ECG.
  • Subjects with a history of atrial arrhythmias should be discussed with the Medical Monitor
  • Family history of congenital long QT syndrome or unexplained cardiac death
  • Symptomatic heart failure (per New York Heart Association guidelines), unstable angina, myocardial infarction, or cerebrovascular accident within 6 months prior to study entry
  • History of ventricular rhythm disturbances
  • History of cardiac arrhythmias, stroke, or myocardial infarction
  • Has a cardiac pacemaker
  • History of pericardial effusion or presence of pericardial effusion on screening echocardiogram
  • Taking any medication known to inhibit the cytochrome P450 (CYP)3A4 isozyme or any drugs that are CYP3A4 inducers, or any drugs associated with torsade de pointes or known to prolong the QTcF interval, including anti-arrhythmic medications within 2 weeks prior to screening
  • Uncontrolled intercurrent illness that would limit compliance with study requirements
  • 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
  • Being aphakic due to previous cataract surgery or congenital abnormality

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
Salpi Siyahian
415-502-3618
Salpi.Siyahian@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
Brianna Lambert
773-834-7480
blambert@medicine.bsd.uchicago.edu

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
Peggy Healy
617-636-8117
mhealy2@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
Joanne Lauber
314-747-3879
jlauber@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
Sharon Johnson
434-924-1979
sfj8n@virginia.edu

Wisconsin
Medical College of Wisconsin
Disha Chheda
414-805-7292
dchheda@mcw.edu
Principal Investigator: Ashraf El-Meanawy, MD