A Study of the Long-Term Safety, Tolerability, and Effectiveness of Tesevatinib for Patients Completing 24 Months of Treatment for Autosomal Dominant Polycystic Kidney Disease

Overview

About this study

The purpose of this study is to assess the long term safety, tolerability, and effectiveness of tesevatinib for patients with autosomal dominant polycystic kidney disease, who started and completed 24 months of treatment for previous study KD019-101.

 

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Ziad El-Zoghby, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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