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

NCT01559363

CompletedPhase 1, Phase 2

Sponsor: Kadmon, a Sanofi Company

Conditions: Polycystic Kidney, Autosomal Dominant

Interventions: Tesevatinib

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 62 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Locations (11)

Los Angeles, California, United States
Denver, Colorado, United States
Kansas City, Kansas, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
New York, New York, United States
Cleveland, Ohio, United States
San Antonio, Texas, United States
Charlottesville, Virginia, United States
Milwaukee, Wisconsin, United States