Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 60
Updated:3/22/2019
Start Date:August 9, 2017
End Date:August 10, 2020
Contact:Director of Clinical Operations
Email:KD019-211@kadmon.com
Phone:724-778-6125

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A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects With Autosomal Dominant Polycystic Kidney Disease

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

Safety and efficacy of 50mg tesevatinib in comparison to placebo in patients with autosomal
dominant polycystic kidney disease (ADPKD) will be assessed.

The primary purpose of this study is focused on evaluating the change from baseline in
height-adjusted total kidney volume (htTKV) as measured by magnetic resonance imaging (MRI)
at Months 12, 18, and 24 in patients with ADPKD treated with tesevatinib or placebo.

If eligible for the study participation, subjects will be randomly assigned to either
investigational treatment group or placebo group. Treatment group will receive 50mg
tesevatinib once daily for 24 months and control group will receive the placebo once daily
for 24 months.

Inclusion Criteria:

- ADPKD diagnosis based on Ravine's criteria

- Cysts of at least 1 cm

- eGFR ≥ 25 mL/min/1.73 m2 and ≤ 90 mL/min/1.73 m2, using the Modification of Diet in
Renal Disease-4 variable formula

- htTKV must meet the following requirements: ≥ 500 mL for subjects 18-35 years of age;
≥ 750 mL for subjects 36-49 years of age; ≥ 900 mL for subjects 50-60 years of age

- 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 ≤ 1.5 x ULN Lipase ≤ 1.5 X ULN 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
We found this trial at
20
sites
Los Angeles, California 90095
310-825-4321
Principal Investigator: Anjay Rastogi, MD
Phone: 310-825-7919
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Principal Investigator: Frederic Rahbari-Oskoui, MD
Phone: 404-712-1162
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Ronald Perrone, MD
Phone: 617-636-7914
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Theodore I. Steinman, MD
Phone: 617-667-0317
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Bharathi Reddy, MD
Phone: 773-834-3237
University of Chicago One of the world's premier academic and research institutions, the University of...
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Michel Chonchol, MD
Phone: 303-724-7790
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Steve Seliger, MD, MS
Phone: 410-328-0207
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Mitchell Rosner, MD
Phone: 434-924-1572
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Pranav Garimella, MD
Phone: 619-786-2854
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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La Mesa, California 91942
Principal Investigator: George Fadda, MD
Phone: 619-461-3894
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Ashraf El-Meanawy, MD
Phone: 414-805-7208
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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333 Cedar Street
New Haven, Connecticut 06520
Principal Investigator: Neera Dahl, MD
Phone: 203-737-1575
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New York, New York 10021
Principal Investigator: Irina Barash, MD
Phone: 212-746-1495
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Simin Goral
Phone: 215-615-4938
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Port Charlotte, Florida 33952
Principal Investigator: Kianoosh Kaveh, DO
Phone: 941-258-3556
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Rochester, Minnesota 55905
Principal Investigator: Ziad El-Zoghby, MD
Phone: 507-266-4616
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Saint Louis, Missouri 63110
Principal Investigator: Seth Goldberg, MD
Phone: 314-286-0819
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San Francisco, California 94143
Principal Investigator: Meyeon Park, MD
Phone: 415-502-3618
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Tampa, Florida 33614
Principal Investigator: Jesus Navarro, MD
Phone: 813-873-1016
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Temple, Texas 76508
Principal Investigator: Mohanram Narayanan, MD
Phone: 254-935-5838
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