Clinical Research

Tesevatinib in Subjects With ADPKD

Sponsored by: Kadmon Corporation, LLC

The goal of the study is to compare and evaluate safety and efficacy of tesevatinib 50mg versus placebo in patients with ADPKD.

Safety and efficacy of 50mg tesevatinib in comparison to placebo in patients with autosomal dominant polycystic kidney disease (ADPKD) will be assessed.

The primary purpose of this study is focused on evaluating the change from baseline in height-adjusted total kidney volume (htTKV) as measured by magnetic resonance imaging (MRI) at Months 12, 18, and 24 in patients with ADPKD treated with tesevatinib or placebo.

If eligible for the study participation, subjects will be randomly assigned to either investigational treatment group or placebo group. Treatment group will receive 50mg tesevatinib once daily for 24 months and control group will receive the placebo once daily for 24 months.

Who can participate?

You may be able to join the study if you have:

  • ADPKD diagnosis based on Ravine's criteria
  • Cysts of at least 1 cm
  • eGFR ≥ 30 mL/min/1.73 m2 and ≤ 80 mL/min/1.73 m2, using the Modification of Diet in Renal Disease-4 variable formula
  • htTKV ≥ 900 mL
  • Have the following laboratory values:

Platelets > lower limit of normal (LLN), Hemoglobin > 9 g/dL, Total bilirubin ≤ 1.5 mg/dL, Aspartate aminotransferase (AST) < 2.5 × upper limit of normal (ULN), Alanine aminotransferase (ALT) < 2.5 × ULN, Prothrombin time/partial thromboplastin time ≤ 1.5 × ULN, Serum potassium levels within normal limits, Serum magnesium levels within normal limits, Albumin ≥ LLN, Amylase within normal limits, Lipase within normal limits, Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.5 × ULN, International normalized ratio (INR) ≤ 1.5, except those subjects taking warfarin who must have INR ≤ 3

  • Female subjects of childbearing potential with negative pregnancy test at screening
  • If sexually active, the subject agrees to use 2 accepted methods of contraception during the course of the study and for 6 months after their last dose of study drug


What will happen during the study?

If you are eligible and agree to participate in the study, you will be required to:

  • Visit the study clinic up to 23 times

  • Have MRI, Echocardiogram, Ocular exam, and ECG procedures 

  • Take the investigational medication daily as directed by the study doctor

  • Have blood and urine tests

  • Drink enough fluids (a minimum of 8 to 12 glasses during the day)

Enrollment is now open.

For more information: visit https://clinicaltrials.ucsf.edu/trial/NCT03203642 and https://clinicaltrials.gov/ct2/show/NCT03203642 

You may also contact [email protected] or Julie Yeh at [email protected] or 415-502-3618.

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The purpose of the REPRISE study is to evaluate the safety and effectiveness of an investigational medication called tolvaptan in patients with late stage 2 to early stage 4 chronic kidney disease caused by autosomal dominant polycystic kidney disease (ADPKD). The kidney function of participants will be checked through frequent blood tests.

The kidneys of people who have ADPKD do not respond correctly to a hormone called vasopressin. It is believed that vasopressin plays a role in the development and growth of kidney cysts. It is hoped that tolvaptan will interfere with or block the effect that vasopressin has on the kidneys to reduce cyst growth and delay kidney failure.

Who can participate?

You may be able to join the study if you are:

  • Between the ages of 18 to 55 years old; patients aged 56 to 65 may be able to participate in some circumstances

  • Diagnosed with ADPKD

There are other criteria that you must meet to participate. The study staff can discuss these criteria with you in greater detail.

What will happen during the study?

If you are eligible and agree to participate in the study, you will be required to:

  • Visit the study clinic up to 25 times. Depending on your circumstances, you may be offered an opportunity to have certain study visits performed at your home or another location more convenient than the study clinic, if this option is available in your region

  • Take the investigational medication twice a day as directed by the study doctor

  • Have blood and urine tests

  • Drink enough fluids (a minimum of 8 to 12 glasses during the day)

For more information: visit www.reprisestudy.com

 

Enrollment is now closed.