Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD

Completed · Phase 2 · Has a placebo group

Conditions studied: Autosomal Dominant Polycystic Kidney, ADPKD

In brief

The goal of the study was to compare and evaluate safety and efficacy of tesevatinib 50 milligrams (mg) versus placebo in participants with autosomal dominant polycystic kidney disease (ADPKD).

Key facts

Study ID

NCT03203642

Run by

Kadmon, a Sanofi Company

People needed

80

Starts

2017-10-12

Expected to finish

2022-01-25

Last updated by the study team

2023-02-06

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ADPKD diagnosis based on Ravine's criteria.
• Cysts of at least 1 centimeter.
• Estimated glomerular filtration rate greater than or equal to (>=) 25 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) and less than or equal to (<=) 90 mL/min/1.73 m\^2, using the Modification of Diet in Renal Disease-4 variable formula.
• htTKV must meet the following requirements: >= 500 milliliters (mL) for participants 18-35 years of age; >= 750 mL for participants 36-49 years of age; >= 900 mL for participants 50-60 years of age.
• The participant had the following laboratory values:
• Platelets greater than (>) lower limit of normal (LLN); Hemoglobin > 9 grams per deciliter; Total bilirubin <= 1.5 milligrams per deciliter; Aspartate aminotransferase less than (<) 2.5*upper limit of normal (ULN); Alanine aminotransferase < 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 <=1.5*ULN; Lipase <=1.5*ULN; Prothrombin time and partial thromboplastin time <=1.5*ULN; International normalized ratio (INR) <=1.5, except those participants taking warfarin who must have INR <=3.
• Female participants of childbearing potential with negative pregnancy test at screening.
• If sexually active, the participant agreed to use 2 accepted methods of contraception during the course of the study and for 6 months after their last dose of study drug.

You may not qualify if…

• Previous nephrectomy.
• Kidney transplant.
• Tuberous sclerosis.
• Hippel-Lindau disease.
• Acquired cystic disease.
• Congenital absence of 1 kidney and/or need for dialysis or transplantation in the foreseeable future.
• Moderate hematuria.
• Uncontrolled hypertension.
• Presence of renal or hepatic calculi (stones) causing symptoms.
• Received any investigational therapy within 30 days prior to initiation of therapy (Day 1 visit).
• Received tolvaptan 30 days prior to initiation of therapy (Day 1 visit).
• Received active treatment for urinary tract infection 4 weeks prior to initiation of therapy (Day 1 visit).
• History of pancreatitis or known risk of pancreatitis.
• The participant met any of the following cardiac criteria:
• Mean QTc interval corrected for heart rate using Fridericia's formula (QTcF) of >450 milliseconds.
• History of torsade de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (< 50 beats per minute), heart block (excluding first-degree block, being PR interval prolongation only), congenital long QT syndrome or new ST segment elevation or depression or new Q wave on electrocardiogram.
• Participants with a history of atrial arrhythmias were discussed with the Medical Monitor.
• Family history of congenital long QT syndrome or unexplained cardiac death.
• Symptomatic heart failure (per New York Heart Association guidelines), unstable angina, myocardial infarction, or cerebrovascular accident within 6 months prior to study entry.
• History of ventricular rhythm disturbances.
• History of cardiac arrhythmias, stroke, or myocardial infarction.
• Has a cardiac pacemaker.
• History of pericardial effusion or presence of pericardial effusion on screening echocardiogram.
• Taking any medication known to inhibit the cytochrome P450 (CYP)3A4 isozyme or any drugs that are CYP3A4 inducers, or any drugs associated with torsade de pointes or known to prolong the QTcF interval, including anti-arrhythmic medications within 2 weeks prior to screening.
• Uncontrolled intercurrent illness that would limit compliance with study requirements.

Where it is running

• University of California San Diego — La Jolla, California, United States
• California Institute for Renal Research — La Mesa, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Yale Nephrology Clinical Research — New Haven, Connecticut, United States
• Coastal Nephrology Associates Research Center, LLC — Port Charlotte, Florida, United States
• Genesis Clinical Research — Tampa, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• University of Maryland — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Rogosin Institute — New York, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Baylor Scott & White Research Institute — Temple, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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