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



Status:Terminated
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 55
Updated:4/17/2018
Start Date:December 2015
End Date:November 2016

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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

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.


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.
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