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

• Status: Completed
• Trial end date: 2019-02-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kadmon Corporation, LLC
• Treatments: XL647

Criteria

Inclusion Criteria:

• The subject has a confirmed diagnosis of ADPKD.

• The subject has a GFR ≥ 35 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

• Normal amylase and lipase levels

• The subject has a htTKV ≥ 1000 mL

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

• History of pericardial effusion or presence of pericardial effusion on screening echocardiogram

• Uncontrolled hypertension

• History of pancreatitis or has known risk factors for pancreatitis

• Subject has received EGFR inhibitor at any time

• The subject is aphakic due to previous cataract surgery or congenital anomaly