A Safety, Pharmacokinetic and Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)


About this study

The primary objective of this study is to determine the safety, plasma pharmacokinetics, and maximum tolerated dose (MTD) of KD019 when administered to subjects with ADPKD.

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:

  • The subject has a confirmed diagnosis of ADPKD.
  • The subject has a GFR ≥ 50 mL/min/1.73 m2.
  • Cysts must be at least 1 cm in size.
  • Adequate bone marrow, kidney, and liver function.
  • Must agree to use two forms of birth control for those of child bearing potential

Exclusion Criteria:

  • The subject has had a previous partial or total nephrectomy.
  • The subject has tuberous sclerosis, Hippel-Lindau disease, or acquired cystic disease.
  • The subject has congenital absence of one kidney and/or need for dialysis.
  • Presence of renal or hepatic calculi (stones) causing symptoms.
  • The subject has received any investigational therapy within 30 days prior to study entry.
  • Active treatment (within 4 weeks of study entry) for urinary tract infection.
  • Subject is known to be immunocompromised
  • Subject is pregnant or nursing
  • Subject is unwilling to do testing required for study

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


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