Tesevatinib in Subjects With ADPKD

Description

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

Study Start Date

August, 09 2017

Estimated Completion Date

August 2020

Interventions

  • Drug: Tesevatinib
  • Drug: Placebo

Study ID

Kadmon Corporation, LLC -- KD019-211

Status

Recruiting

Trial ID

NCT03203642

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

100

Sponsor

Kadmon Corporation, LLC

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

Gender

All

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (50)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Shaelah Huntington 617-667-0317 shunting@bidmc.harvard.edu
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Shaelah Huntington 617-667-0317 shunting@bidmc.harvard.edu
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Shaelah Huntington 617-667-0317 shunting@bidmc.harvard.edu
Tufts Medical Center - Boston, Massachusetts 3.2 miles Carly Tucker 617-636-7914 ctucker@tuftsmedicalcenter.org
Tufts Medical Center - Boston, Massachusetts 3.2 miles Carly Tucker 617-636-7914 ctucker@tuftsmedicalcenter.org
Tufts Medical Center - Boston, Massachusetts 3.2 miles Carly Tucker 617-636-7914 ctucker@tuftsmedicalcenter.org
Yale Nephrology Clinical Research - New Haven, Connecticut 119.2 miles Katrina Blount 203-785-4184 katrina.blount@yale.edu
Rogosin Institute - New York, New York 184.8 miles Ines Chicos 212-746-1578 inc9012@nyp.org
Rogosin Institute - New York, New York 184.8 miles Ines Chicos 212-746-1578 inc9012@nyp.org
Rogosin Institute - New York, New York 184.8 miles Ines Chicos 212-746-1578 inc9012@nyp.org
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Debbra Grier 215-615-4938 Debbra.Grier@uphs.upenn.edu
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Debbra Grier 215-615-4938 Debbra.Grier@uphs.upenn.edu
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Debbra Grier 215-615-4938 Debbra.Grier@uphs.upenn.edu
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Debbra Grier 215-615-4938 Debbra.Grier@uphs.upenn.edu
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Debbra Grier 215-615-4938 Debbra.Grier@uphs.upenn.edu
University of Maryland - Baltimore, Maryland 358.9 miles Charlett Diggs 410-328-0207 cdiggs@som.umaryland.edu
University of Maryland - Baltimore, Maryland 358.9 miles Charlett Diggs 410-328-0207 cdiggs@som.umaryland.edu
University of Maryland - Baltimore, Maryland 358.9 miles Charlett Diggs 410-328-0207 cdiggs@som.umaryland.edu
University of Virginia - Charlottesville, Virginia 493.4 miles Sharon Johnson 434-924-1979 sfj8n@virginia.edu
University of Virginia - Charlottesville, Virginia 493.4 miles Sharon Johnson 434-924-1979 sfj8n@virginia.edu
University of Virginia - Charlottesville, Virginia 493.4 miles Sharon Johnson 434-924-1979 sfj8n@virginia.edu
University of Virginia - Charlottesville, Virginia 493.4 miles Sharon Johnson 434-924-1979 sfj8n@virginia.edu
University of Virginia - Charlottesville, Virginia 493.4 miles Sharon Johnson 434-924-1979 sfj8n@virginia.edu
University of Chicago - Chicago, Illinois 848.0 miles Brittany Ray 773-702-9865 bray10@medicine.bsd.uchicago.edu
University of Chicago - Chicago, Illinois 848.0 miles Brittany Ray 773-702-9865 bray10@medicine.bsd.uchicago.edu
Medical College of Wisconsin - Milwaukee, Wisconsin 862.1 miles Disha Chheda 414-805-7292 dchheda@mcw.edu
Medical College of Wisconsin - Milwaukee, Wisconsin 862.1 miles Disha Chheda 414-805-7292 dchheda@mcw.edu
Medical College of Wisconsin - Milwaukee, Wisconsin 862.1 miles Disha Chheda 414-805-7292 dchheda@mcw.edu
Medical College of Wisconsin - Milwaukee, Wisconsin 862.1 miles Disha Chheda 414-805-7292 dchheda@mcw.edu
Medical College of Wisconsin - Milwaukee, Wisconsin 862.1 miles Disha Chheda 414-805-7292 dchheda@mcw.edu
Emory University School of Medicine - Atlanta, Georgia 932.0 miles Stacie Hitchcock 404-712-1235 shitch2@emory.edu
Emory University School of Medicine - Atlanta, Georgia 932.0 miles Stacie Hitchcock 404-712-1235 shitch2@emory.edu
Washington University - Saint Louis, Missouri 1,039.5 miles Joanne Lauber 314-747-3879 jlauber@wustl.edu
Washington University - Saint Louis, Missouri 1,039.5 miles Joanne Lauber 314-747-3879 jlauber@wustl.edu
Washington University - Saint Louis, Missouri 1,039.5 miles Joanne Lauber 314-747-3879 jlauber@wustl.edu
Washington University - Saint Louis, Missouri 1,039.5 miles Joanne Lauber 314-747-3879 jlauber@wustl.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Lisa Bungum 507-266-4616 bungum.lisa2@mayo.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Lisa Bungum 507-266-4616 bungum.lisa2@mayo.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Lisa Bungum 507-266-4616 bungum.lisa2@mayo.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Lisa Bungum 507-266-4616 bungum.lisa2@mayo.edu
Genesis Clinical Research - Tampa, Florida 1,183.5 miles Cassie Miller 813-873-1016 cassiemiller@genesisclinicaltrials.com
Coastal Nephrology Associates Research Center LLC - Port Charlotte, Florida 1,249.0 miles Beth Jackman 941-258-3556 bjack302@gmail.com
Coastal Nephrology Associates Research Center LLC - Port Charlotte, Florida 1,249.0 miles Beth Jackman 941-258-3556 bjack302@gmail.com
Coastal Nephrology Associates Research Center LLC - Port Charlotte, Florida 1,249.0 miles Beth Jackman 941-258-3556 bjack302@gmail.com
Coastal Nephrology Associates Research Center LLC - Port Charlotte, Florida 1,249.0 miles Beth Jackman 941-258-3556 bjack302@gmail.com
Coastal Nephrology Associates Research Center LLC - Port Charlotte, Florida 1,249.0 miles Beth Jackman 941-258-3556 bjack302@gmail.com
University of Colorado Denver - Aurora, Colorado 1,759.8 miles Beverly Farmer 303-724-7790 beverly.farmer@ucdenver.edu
California Institute for Renal Research - La Mesa, California 2,573.5 miles Irish Lardizaball 619-461-3894 ilardizabal@cairr.com
University of California Los Angeles - Los Angeles, California 2,605.2 miles Farid Arman 310-825-7919 PKD@mednet.ucla.edu
University of California San Francisco - San Francisco, California 2,699.8 miles Salpi Siyahian 415-502-3618 Salpi.Siyahian@ucsf.edu

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