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Trial record 2 of 3 for:    tesevatinib | ADPKD

Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02616055
Recruitment Status : Terminated (Sponsor opened Phase 2 Study.)
First Posted : November 26, 2015
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Kadmon Corporation, LLC

Brief Summary:
Subjects who received tesevatinib in Study KD019-101 and completed 24 months of treatment will continue on the dose of tesevatinib they were receiving at 24 months on the KD019-101 study.

Condition or disease Intervention/treatment Phase
Autosomal Dominant Polycystic Kidney Disease (ADPKD) Drug: tesevatinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Extension Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101 in Subjects With Autosomal Dominant Polycystic Kidney Disease
Study Start Date : December 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: 50mg Daily
One 50mg tesevatinib tablet per day
Drug: tesevatinib
Other Names:
  • KD019
  • XL647

Experimental: 100mg Daily
Two 50mg tesevatinib tablets per day
Drug: tesevatinib
Other Names:
  • KD019
  • XL647

Experimental: 150mg M/Th
Three 50mg tesevatinib tablets every Monday and Thursday.
Drug: tesevatinib
Other Names:
  • KD019
  • XL647

Experimental: 150mg MWF
Three 50mg tesevatinib tablets every Monday, Wednesday and Friday.
Drug: tesevatinib
Other Names:
  • KD019
  • XL647




Primary Outcome Measures :
  1. Monitor Longitudinal Changes in Estimated Glomerular Filtration Rate [ Time Frame: 37 Months ]
    Monitor longitudinal changes in estimated glomerular filtration rate (eGFR) in subjects with ADPKD when treated with tesevatinib.


Secondary Outcome Measures :
  1. Monitor Longitudinal Changes in Total Kidney Volume [ Time Frame: 37 Months ]
    Monitor longitudinal changes from baseline in total kidney volume (TKV) in subjects with ADPKD when treated with tesevatinib.

  2. Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 37 Months ]
    To evaluate the long term safety and tolerability of tesevatinib in subjects with ADPKD when treated with tesevatinib.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject must have received 24 months of treatment with tesevatinib on study KD019-101. (Twenty-four months of study drug treatment includes days without treatment that were allowed by the KD019-101 protocol.)
  • Sexually active subject (male and female) has agreed to use two forms of accepted methods of contraception during the course of the study and for 3 months after the last dose of study drug. Effective birth control includes (a) IUD plus one barrier method; (b) on stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method; or (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm).
  • Female subjects of childbearing potential have a negative pregnancy test at screening. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression.

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): NCT02616055


Locations
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United States, California
UCLA Medical Center
Los Angeles, California, United States, 90025
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Virginia
University of Virginia - Nephrology Clinical Research Center
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Kadmon Corporation, LLC

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Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT02616055     History of Changes
Other Study ID Numbers: KD019-207
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: August 2017

Additional relevant MeSH terms:
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Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Ciliopathies
Genetic Diseases, Inborn
XL647
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action