Trial · NCT01559363

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

NCT01559363, Phase 1, Phase 2, Completed, Kadmon, a Sanofi Company; results first posted 2022-11-08

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Safety, Pharmacokinetic & Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney Disease. Trials, record NCT01559363. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01559363

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Safety, Pharmacokinetic & Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney Disease
NCT number: NCT01559363
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 69 participants, actual
Lead sponsor: Kadmon, a Sanofi Company
Conditions: Polycystic Kidney, Autosomal Dominant
Interventions: Tesevatinib
First posted: 2012-03-21
Last updated: 2022-11-08
Results first posted: 2022-11-08

Source ClinicalTrials.gov

Registered outcomes28

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)	From Baseline (Day 1) until 30 days after the last dose of study drug (maximum duration: up to 37 months)	An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product and which did not necessarily had to have a causal relationship with the treatment. An SAE was any untoward medical occurrence at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were AEs that developed or worsened or became serious from the first dose (Day 1) of the study drug until 30 days after the last dose of study drug.
Primary	Phase 1b: Pharmacokinetics (PK): Plasma Concentrations of Tesevatinib 100 mg and 150 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	Plasma concentrations of tesevatinib was analyzed using non-compartmental analysis.
Primary	Phase 1b: Pharmacokinetics: Plasma Concentrations of Tesevatinib 50 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	Plasma concentrations of tesevatinib was analyzed using non-compartmental analysis.
Primary	Phase 1b: Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Tesevatinib 100 mg and 150 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	Cmax was defined as maximum observed plasma concentration.
Primary	Phase 1b: Pharmacokinetics: Maximum Observed Plasma Concentration of Tesevatinib 50 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	Cmax was defined as maximum observed plasma concentration.
Primary	Phase 1b: Pharmacokinetics: Time of the Maximum Observed Plasma Concentration (Tmax) of Tesevatinib 100 mg and 150 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	Tmax was defined as time to reach maximum observed plasma concentration.
Primary	Phase 1b: Pharmacokinetics: Time of the Maximum Observed Plasma Concentration of Tesevatinib 50 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	Tmax was defined as time to reach maximum observed plasma concentration.
Primary	Phase 1b: Pharmacokinetics: Time of the Last Quantifiable Plasma Concentration (Tlast) of Tesevatinib 100 mg and 150 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	Tlast was defined as time to reach last quantifiable plasma concentration.
Primary	Phase 1b: Pharmacokinetics: Time of the Last Quantifiable Plasma Concentration of Tesevatinib 50 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	Tlast was defined as time to reach last quantifiable plasma concentration.
Primary	Phase 1b: Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-t) of Tesevatinib 100 mg and 150 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	AUC0-last was defined as area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (tlast).

1 to 10 of 28Source ClinicalTrials.gov

See all 28 registered outcomes

Outcomes28

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)	From Baseline (Day 1) until 30 days after the last dose of study drug (maximum duration: up to 37 months)	Analysis was performed on safety population.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Phase 1b: Pharmacokinetics (PK): Plasma Concentrations of Tesevatinib 100 mg and 150 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	Analysis was performed on PK Population which consisted of all participants who received at least one dose of tesevatinib 100 mg (in Phase 1b: Cohort 2) and 150 mg (in Phase 1b: Cohort 3) and had quantifiable PK data available. Here, 'number analyzed' = participants with available data for each specified category.	nanograms per milliliter (ng/mL)	MEAN
PRIMARY	Phase 1b: Pharmacokinetics: Plasma Concentrations of Tesevatinib 50 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	Analysis was performed on PK Population which consisted of all participants who received at least one dose of tesevatinib 50 mg in Phase 1b and had quantifiable PK data available. Here, overall number of participants analyzed = participants evaluable for this outcome measure (OM) and 'number analyzed' = participants with available data for each specified category.	ng/mL	MEAN
PRIMARY	Phase 1b: Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Tesevatinib 100 mg and 150 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	Analysis was performed on PK Population.	ng/mL	MEAN
PRIMARY	Phase 1b: Pharmacokinetics: Maximum Observed Plasma Concentration of Tesevatinib 50 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	Analysis was performed on PK Population. Here, overall number of participants analyzed = participants evaluable for this OM and 'number analyzed' = participants with available data for each specified category.	ng/mL	MEAN
PRIMARY	Phase 1b: Pharmacokinetics: Time of the Maximum Observed Plasma Concentration (Tmax) of Tesevatinib 100 mg and 150 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	Analysis was performed on PK Population.	hours	MEAN
PRIMARY	Phase 1b: Pharmacokinetics: Time of the Maximum Observed Plasma Concentration of Tesevatinib 50 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	Analysis was performed on PK Population. Here, overall number of participants analyzed = participants evaluable for this OM and 'number analyzed' = participants with available data for each specified category.	hours	MEAN
PRIMARY	Phase 1b: Pharmacokinetics: Time of the Last Quantifiable Plasma Concentration (Tlast) of Tesevatinib 100 mg and 150 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	Analysis was performed on PK Population. Here, 'number analyzed' = participants with available data for each specified category.	hours	MEAN
PRIMARY	Phase 1b: Pharmacokinetics: Time of the Last Quantifiable Plasma Concentration of Tesevatinib 50 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	Analysis was performed on PK Population. Here, overall number of participants analyzed = participants evaluable for this OM and 'number analyzed' = participants with available data for each specified category.	hours	MEAN
PRIMARY	Phase 1b: Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-t) of Tesevatinib 100 mg and 150 mg	Pre-dose, 1, 2, 4, 8, and 24 hours post-dose on day 1 and pre-dose, 1, 2, 4, and 24 hours post-dose on Day 14	Analysis was performed on PK Population. Here, 'number analyzed' = participants with available data for each specified category.	hournanograms per milliliter (hrng/mL)	MEAN

1 to 10 of 28Source ClinicalTrials.gov

See all 28 outcomes

Results by group289

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)	Phase 1b: Cohort 1: Tesevatinib 50 mg Once Daily Dosing	TEAEs	24		Participants
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)	Phase 1b: Cohort 2: Tesevatinib 100 mg Once Daily Dosing	TEAEs	8		Participants
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)	Phase 1b: Cohort 3: Tesevatinib 150 mg Once Daily Dosing	TEAEs	5		Participants
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)	Phase 1b: Cohort 1: Tesevatinib 50 mg Once Daily Dosing	SAE	1		Participants
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)	Phase 1b: Cohort 2: Tesevatinib 100 mg Once Daily Dosing	SAE	0		Participants
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)	Phase 1b: Cohort 3: Tesevatinib 150 mg Once Daily Dosing	SAE	0		Participants
Phase 1b: Pharmacokinetics (PK): Plasma Concentrations of Tesevatinib 100 mg and 150 mg	Phase 1b: Cohort 2: Tesevatinib 100 mg Once Daily Dosing	Day 1: Pre-dose	0	Standard Deviation 0	nanograms per milliliter (ng/mL)
Phase 1b: Pharmacokinetics (PK): Plasma Concentrations of Tesevatinib 100 mg and 150 mg	Phase 1b: Cohort 3: Tesevatinib 150 mg Once Daily Dosing	Day 1: Pre-dose	0	Standard Deviation 0	nanograms per milliliter (ng/mL)
Phase 1b: Pharmacokinetics (PK): Plasma Concentrations of Tesevatinib 100 mg and 150 mg	Phase 1b: Cohort 2: Tesevatinib 100 mg Once Daily Dosing	Day 1: 1 hour post-dose	4.39	Standard Deviation 2.78	nanograms per milliliter (ng/mL)
Phase 1b: Pharmacokinetics (PK): Plasma Concentrations of Tesevatinib 100 mg and 150 mg	Phase 1b: Cohort 3: Tesevatinib 150 mg Once Daily Dosing	Day 1: 1 hour post-dose	8.41	Standard Deviation 5.84	nanograms per milliliter (ng/mL)

1 to 10 of 289Source ClinicalTrials.gov

See all 289 results by group

Participant flow36

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Phase 1b: Up to 36 Months	STARTED	Phase 1b: Cohort 1: Tesevatinib 50 mg Once Daily Dosing	24
Phase 1b: Up to 36 Months	STARTED	Phase 1b: Cohort 2: Tesevatinib 100 mg Once Daily Dosing	8
Phase 1b: Up to 36 Months	STARTED	Phase 1b: Cohort 3: Tesevatinib 150 mg Once Daily Dosing	5
Phase 1b: Up to 36 Months	STARTED	Phase 2a: Cohort 4: Tesevatinib: Bi-weekly Dosing	0
Phase 1b: Up to 36 Months	STARTED	Phase 2a: Cohort 5: Tesevatinib: Tri-weekly Dosing	0
Phase 1b: Up to 36 Months	STARTED	Phase 2a: SILK Cohort: Tesevatinib 50 mg Once Daily Dosing	0
Phase 1b: Up to 36 Months	COMPLETED	Phase 1b: Cohort 1: Tesevatinib 50 mg Once Daily Dosing	18
Phase 1b: Up to 36 Months	COMPLETED	Phase 1b: Cohort 2: Tesevatinib 100 mg Once Daily Dosing	5
Phase 1b: Up to 36 Months	COMPLETED	Phase 1b: Cohort 3: Tesevatinib 150 mg Once Daily Dosing	3
Phase 1b: Up to 36 Months	COMPLETED	Phase 2a: Cohort 4: Tesevatinib: Bi-weekly Dosing	0

1 to 10 of 36Source ClinicalTrials.gov

See all 36 participant flow

Adverse events1,362

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	Phase 1b: Cohort 1: Tesevatinib 50 mg Once Daily Dosing	10	24
other	Diarrhoea	Gastrointestinal disorders	Phase 1b: Cohort 2: Tesevatinib 100 mg Once Daily Dosing	4	8
other	Diarrhoea	Gastrointestinal disorders	Phase 1b: Cohort 3: Tesevatinib 150 mg Once Daily Dosing	2	5
other	Diarrhoea	Gastrointestinal disorders	Phase 2a: Cohort 4: Tesevatinib: Bi-weekly Dosing	5	10
other	Diarrhoea	Gastrointestinal disorders	Phase 2a: Cohort 5: Tesevatinib: Tri-weekly Dosing	6	14
other	Diarrhoea	Gastrointestinal disorders	Phase 2a: SILK Cohort: Tesevatinib 50 mg Once Daily Dosing	2	8
other	Nausea	Gastrointestinal disorders	Phase 1b: Cohort 1: Tesevatinib 50 mg Once Daily Dosing	10	24
other	Nausea	Gastrointestinal disorders	Phase 1b: Cohort 2: Tesevatinib 100 mg Once Daily Dosing	2	8
other	Nausea	Gastrointestinal disorders	Phase 1b: Cohort 3: Tesevatinib 150 mg Once Daily Dosing	2	5
other	Nausea	Gastrointestinal disorders	Phase 2a: Cohort 4: Tesevatinib: Bi-weekly Dosing	2	10

1 to 10 of 1,362Source ClinicalTrials.gov

See all 1,362 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase 1b: Cohort 1: Tesevatinib 50 mg Once Daily Dosing	0	24
Total, all-cause mortality	Phase 1b: Cohort 2: Tesevatinib 100 mg Once Daily Dosing	0	8
Total, all-cause mortality	Phase 1b: Cohort 3: Tesevatinib 150 mg Once Daily Dosing	0	5
Total, all-cause mortality	Phase 2a: Cohort 4: Tesevatinib: Bi-weekly Dosing	0	10
Total, all-cause mortality	Phase 2a: Cohort 5: Tesevatinib: Tri-weekly Dosing	0	14
Total, all-cause mortality	Phase 2a: SILK Cohort: Tesevatinib 50 mg Once Daily Dosing	0	8
Total, other adverse events	Phase 1b: Cohort 1: Tesevatinib 50 mg Once Daily Dosing	24	24
Total, other adverse events	Phase 1b: Cohort 2: Tesevatinib 100 mg Once Daily Dosing	8	8
Total, other adverse events	Phase 1b: Cohort 3: Tesevatinib 150 mg Once Daily Dosing	5	5
Total, other adverse events	Phase 2a: Cohort 4: Tesevatinib: Bi-weekly Dosing	10	10

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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