Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Conditions
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.
Interventions
DRUGtesevatinib
Sponsors
Kadmon Corporation, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Extension Study, participants to be followed at the dose of tesevatinib they were receiving in Study KD019-101.
Eligibility
Sex/Gender
ALL
Age
18 Years to 62 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monitor Longitudinal Changes in Estimated Glomerular Filtration Rate | 37 Months | Monitor longitudinal changes in estimated glomerular filtration rate (eGFR) in subjects with ADPKD when treated with tesevatinib. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monitor Longitudinal Changes in Total Kidney Volume | 37 Months | Monitor longitudinal changes from baseline in total kidney volume (TKV) in subjects with ADPKD when treated with tesevatinib. |
| Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability | 37 Months | To evaluate the long term safety and tolerability of tesevatinib in subjects with ADPKD when treated with tesevatinib. |
Countries
United States
Outcome results
None listed