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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 June 2022
• Main ID: NCT01559363
• Date of registration: 09/03/2012
• Prospective Registration: Yes
• Primary sponsor: Kadmon, a Sanofi Company
• Public title: A Safety, Pharmacokinetic & Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney Disease
• Scientific title: A Phase 1b/2a, Safety, Pharmacokinetic and Dose-Escalation Study of KD019 ((Tesevatinib) in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
• Date of first enrolment: December 7, 2012
• Target sample size: 74
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01559363
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 62 Years
Gender: All

Health Condition(s) or Problem(s) studied

Polycystic Kidney, Autosomal Dominant

Intervention(s)

Drug: KD019 (tesevatinib)

Primary Outcome(s)

Safety, Plasma Pharmacokinetics and Maximum Tolerated Dose of KD019 [Time Frame: 24 months]

Glomerular Filtration Rate [Time Frame: 24 months]

Secondary Outcome(s)

Safety, Tolerability, and Pharmacokinetics of an Alternative Dosing Schedule [Time Frame: 24 months]

Serum Creatinine [Time Frame: 24 months]

Total Kidney Volume [Time Frame: 24 months]

Secondary ID(s)

KD019-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors