Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03203642 |
Recruitment Status :
Completed
First Posted : June 29, 2017
Last Update Posted : June 1, 2022
|
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | June 26, 2017 | ||||
First Posted Date ICMJE | June 29, 2017 | ||||
Last Update Posted Date | June 1, 2022 | ||||
Actual Study Start Date ICMJE | October 12, 2017 | ||||
Actual Primary Completion Date | January 25, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Safety and Tolerability of tesevatinib 50mg administered once daily in patients with ADPKD measured as incidence of treatment-emergent adverse events. [ Time Frame: 24 months ] Incidence of adverse events occurring at the duration of the study will be identified with the following assessments: 12-lead ECGs, ocular evaluations, clinical laboratory tests, echocardiograms, and physical exams.
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD | ||||
Official Title ICMJE | A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects With Autosomal Dominant Polycystic Kidney Disease | ||||
Brief Summary | The goal of the study is to compare and evaluate safety and efficacy of tesevatinib 50mg versus placebo in patients with ADPKD. | ||||
Detailed Description | Safety and efficacy of 50mg tesevatinib in comparison to placebo in patients with autosomal dominant polycystic kidney disease (ADPKD) will be assessed. The primary purpose of this study is focused on evaluating the change from baseline in height-adjusted total kidney volume (htTKV) as measured by magnetic resonance imaging (MRI) at Months 12, 18, and 24 in patients with ADPKD treated with tesevatinib or placebo. If eligible for the study participation, subjects will be randomly assigned to either investigational treatment group or placebo group. Treatment group will receive 50mg tesevatinib once daily for 24 months and control group will receive the placebo once daily for 24 months. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||
Condition ICMJE |
|
||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
80 | ||||
Original Estimated Enrollment ICMJE |
100 | ||||
Actual Study Completion Date ICMJE | January 25, 2022 | ||||
Actual Primary Completion Date | January 25, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Platelets > lower limit of normal (LLN) Hemoglobin > 9 g/dL Total bilirubin ≤ 1.5 mg/dL Aspartate aminotransferase (AST) < 2.5 × upper limit of normal (ULN) Alanine aminotransferase (ALT) < 2.5 × ULN Prothrombin time/partial thromboplastin time ≤ 1.5 × ULN Serum potassium levels within normal limits Serum magnesium levels within normal limits Albumin ≥ LLN Amylase ≤ 1.5 x ULN Lipase ≤ 1.5 X ULN Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5, except those subjects taking warfarin who must have INR ≤ 3
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years to 60 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03203642 | ||||
Other Study ID Numbers ICMJE | ACT17675 KD019-211 ( Other Identifier: Kadmon ) |
||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Current Responsible Party | Sanofi ( Kadmon, a Sanofi Company ) | ||||
Original Responsible Party | Kadmon Corporation, LLC | ||||
Current Study Sponsor ICMJE | Kadmon, a Sanofi Company | ||||
Original Study Sponsor ICMJE | Kadmon Corporation, LLC | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Sanofi | ||||
Verification Date | May 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |