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 |
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.
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.
We found this trial at
6
sites
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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