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

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ClinicalTrials.gov Identifier: NCT03203642
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Kadmon Corporation, LLC

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

Condition or disease Intervention/treatment Phase
Autosomal Dominant Polycystic Kidney ADPKD Drug: Tesevatinib Drug: Placebo Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects With Autosomal Dominant Polycystic Kidney Disease
Actual Study Start Date : August 9, 2017
Estimated Primary Completion Date : August 10, 2020
Estimated Study Completion Date : August 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
50mg tesevatinib administered once daily for up to 24 months.
Drug: Tesevatinib
A once daily dose of tesevatinib 50 mg in a round tablet form of white to off-white color.
Other Name: KD019

Placebo Comparator: Control Group
Matching placebo administered once daily for up to 24 months.
Drug: Placebo
A once daily dose of matching placebo.




Primary Outcome Measures :
  1. Change of height-adjusted total kidney volume (htTKV) in participants with ADPKD treated with tesevatinib 50mg or placebo. [ Time Frame: 12 months ]
    Change from baseline of the htTKV will be measured by magnetic resonance imaging (MRI) at Months: 12.

  2. Change of height-adjusted total kidney volume (htTKV) in participants with ADPKD treated with tesevatinib 50mg or placebo. [ Time Frame: 18 month ]
    Change from baseline of the htTKV will be measured by magnetic resonance imaging (MRI) at Months: 18.

  3. Change of height-adjusted total kidney volume (htTKV) in participants with ADPKD treated with tesevatinib 50mg or placebo. [ Time Frame: 24 month ]
    Change from baseline of the htTKV will be measured by magnetic resonance imaging (MRI) at Months: 24.


Secondary Outcome Measures :
  1. Safety and Tolerability of tesevatinib 50mg administered once daily in patients with ADPKD measured as incidence of treatment-emergent adverse events. [ Time Frame: 24 months ]
    Incidence of adverse events occurring at the duration of the study will be identified with the following assessments: 12-lead ECGs, ocular evaluations, clinical laboratory tests, echocardiograms, and physical exams.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203642


Contacts
Contact: Associate Director of Clinical Operations 724-778-6125 KD019-211@kadmon.com

Locations
United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Jeff Ledford-Mills    619-786-2854    jhmills@ucsd.edu   
Principal Investigator: Pranav Garimella, MD         
California Institute for Renal Research Recruiting
La Mesa, California, United States, 91942
Contact: Irish Lardizaball    619-461-3894    ilardizabal@cairr.com   
Principal Investigator: George Fadda, MD         
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Farid Arman    310-825-7919    PKD@mednet.ucla.edu   
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Julie Yeh    415-502-3618    chia-lin.yeh@ucsf.edu   
Principal Investigator: Meyeon Park, MD         
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Beverly Farmer    303-724-7790    beverly.farmer@ucdenver.edu   
Principal Investigator: Michel Chonchol, MD         
United States, Connecticut
Yale Nephrology Clinical Research Recruiting
New Haven, Connecticut, United States, 06520
Contact: Katrina Blount    203-737-1575    katrina.blount@yale.edu   
United States, Florida
Coastal Nephrology Associates Research Center, LLC Recruiting
Port Charlotte, Florida, United States, 33952
Contact: Beth Jackman    941-258-3556    bjack302@gmail.com   
Principal Investigator: Kianoosh Kaveh, DO         
Genesis Clinical Research Recruiting
Tampa, Florida, United States, 33614
Contact: Cassie Miller    813-873-1016    cassiemiller@genesisclinicaltrials.com   
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Zohreh Forghani    404-712-1162    zohreh.forghani@emory.edu   
Principal Investigator: Frederic Rahbari-Oskoui, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Sharon Trevino    773-702-6201    strevino@bsd.uchicago.edu   
Contact: Jyotsna Soundararajan    773-834-3237    jsoundararajan@medicine.bsd.uchicago.edu   
Principal Investigator: Bharathi Reddy, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Charlett Diggs    410-328-0207    cdiggs@som.umaryland.edu   
Principal Investigator: Steve Seliger, MD, MS         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Carly Tucker    617-636-7914    ctucker@tuftsmedicalcenter.org   
Principal Investigator: Ronald Perrone, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Shaelah Huntington    617-667-0317    shunting@bidmc.harvard.edu   
Principal Investigator: Theodore I. Steinman, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lisa Bungum    507-266-4616    bungum.lisa2@mayo.edu   
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Sue Dombek    314-286-0819    dombeks@wustl.edu   
Principal Investigator: Seth Goldberg, MD         
United States, New York
Rogosin Institute Recruiting
New York, New York, United States, 10021
Contact: Stephanie L Donahue, NP    212-746-1495    sld9001@nyp.org   
Principal Investigator: Irina Barash, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Debbra Grier    215-615-4938    Debbra.Grier@uphs.upenn.edu   
United States, Texas
Baylor Scott & White Research Institute Recruiting
Temple, Texas, United States, 10016
Contact: Ashley Sauls, BS    254-935-5838    Ashley.Kossie@BSWHealth.org   
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Sharon Johnson    434-924-1979    sfj8n@virginia.edu   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Ashley Schwarz    414-805-7208    aschwarz@mcw.edu   
Principal Investigator: Ashraf El-Meanawy, MD         
Sponsors and Collaborators
Kadmon Corporation, LLC

Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT03203642     History of Changes
Other Study ID Numbers: KD019-211
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kadmon Corporation, LLC:
ADPKD
Autosomal Dominant Polycystic Kidney Disease
Polycystic Kidney
Tesevatinib
Polycystic Kidney Disease
PKD

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn