A Safety, Pharmacokinetic & Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney Disease

Completed · Phase 1/Phase 2

Conditions studied: Polycystic Kidney, Autosomal Dominant

In brief

The primary objective of this study Phase 1b was to determine the safety, plasma pharmacokinetics, and maximum tolerated dose (MTD) of tesevatinib when administered to participants with autosomal dominant polycystic kidney disease (ADPKD). The primary objective of this study Phase 2a was to evaluate the annualized change in glomerular filtration rate (GFR) in participants with ADPKD when treated with tesevatinib.

Key facts

Study ID

NCT01559363

Run by

Kadmon, a Sanofi Company

People needed

69

Starts

2012-10-11

Expected to finish

2019-02-08

Last updated by the study team

2022-11-08

Who can join

Age: 18 and older, up to 62. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The participant had a confirmed diagnosis of ADPKD.
• The participant had a GFR >=35 mL/min/1.73m\^2.
• Cysts must be at least 1 centimeter in size.
• Adequate bone marrow, kidney, and liver function.
• Must agree to use two forms of birth control for those of child bearing potential.
• Normal amylase and lipase levels.
• The participant had a htTKV >= 1000 mL (htTKV was calculated using total kidney volume obtained from magnetic resonance imaging divided by height in meters).

You may not qualify if…

• The participant has had a previous partial or total nephrectomy.
• The participant had tuberous sclerosis, Hippel-Lindau disease, or acquired cystic disease.
• The participant had congenital absence of one kidney and/or need for dialysis.
• Presence of renal or hepatic calculi (stones) causing symptoms.
• The participant had received any investigational therapy within 30 days prior to study entry.
• Active treatment (within 4 weeks of study entry) for urinary tract infection.
• Participant was known to be immunocompromised.
• Participant was pregnant or nursing.
• History of pericardial effusion or presence of pericardial effusion on screening echocardiogram
• Uncontrolled hypertension.
• History of pancreatitis or had known risk factors for pancreatitis.
• Participant had received EGFR inhibitor at any time.
• The participant was aphakic due to previous cataract surgery or congenital anomaly.

Where it is running

• UCLA Medical Center — Los Angeles, California, United States
• University of Colorado Denver — Denver, Colorado, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• New York University School of Medicine — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Clinical Advancement Center, PLLC — San Antonio, Texas, United States
• University of Virginia - Nephrology Clinical Research Center — Charlottesville, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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