Autosomal Dominant Polycystic Kidney Disease (ADPKD)Phase 2NCT02616055
Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101
A Phase 2 study testing tesevatinib in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Kadmon Corporation, LLC at 6 sites in United States.
Trial summary
Subjects who received tesevatinib in Study KD019-101 and completed 24 months of treatment will continue on the dose of tesevatinib they were receiving at 24 months on the KD019-101 study. Read more about this study
- Who is it for?
- Ages 18 to 62 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- What is being tested?
- tesevatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 6 sitesUnited States
- Study dates
- 25 Dec 2015to 21 Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The subject must have received 24 months of treatment with tesevatinib on study KD019-101. (Twenty-four months of study drug treatment includes days without treatment that were allowed by the KD019-101 protocol.)
- Sexually active subject (male and female) has agreed to use two forms of accepted methods of contraception during the course of the study and for 3 months after the last dose of study drug. Effective birth control includes (a) IUD plus one barrier method; (b) on stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method; or (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm).
- Female subjects of childbearing potential have a negative pregnancy test at screening. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Virginia - Nephrology Clinical Research Center
Charlottesville, Virginia, 22908
Cleveland Clinic
Cleveland, Ohio, 44195
UCLA Medical Center
Los Angeles, California, 90025
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101 in Subjects With Autosomal Dominant Polycystic Kidney Disease
Subjects who received tesevatinib in Study KD019-101 and completed 24 months of treatment will continue on the dose of tesevatinib they were receiving at 24 months on the KD019-101 study.
- Being tested
- tesevatinib
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tesevatinibDrug
Also called KD019, XL647
| Study group | Role | What they receive |
|---|---|---|
| 50mg Daily | Experimental | One 50mg tesevatinib tablet per day Receives: Drug: tesevatinib |
| 100mg Daily | Experimental | Two 50mg tesevatinib tablets per day Receives: Drug: tesevatinib |
| 150mg M/Th | Experimental | Three 50mg tesevatinib tablets every Monday and Thursday. Receives: Drug: tesevatinib |
| 150mg MWF | Experimental | Three 50mg tesevatinib tablets every Monday, Wednesday and Friday. Receives: Drug: tesevatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitor Longitudinal Changes in Estimated Glomerular Filtration Rate
Monitor longitudinal changes in estimated glomerular filtration rate (eGFR) in subjects with ADPKD when treated with tesevatinib.
Measured: 37 Months
Secondary outcomes (2)
Monitor Longitudinal Changes in Total Kidney Volume
Monitor longitudinal changes from baseline in total kidney volume (TKV) in subjects with ADPKD when treated with tesevatinib.
Measured: 37 Months
Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability
To evaluate the long term safety and tolerability of tesevatinib in subjects with ADPKD when treated with tesevatinib.
Measured: 37 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study start25 Dec 2015
- Primary completion21 Dec 2016
- Study completion21 Dec 2016
Why it stopped: Sponsor opened Phase 2 Study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Extension Study, participants to be followed at the dose of tesevatinib they were receiving in Study KD019-101.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kadmon Corporation, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616055
- Sponsor's protocol ID
- KD019-207
- Status last verified
- May 2022
- First submitted
- 24 Nov 2015
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101 in Subjects With Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT02616055
- Acronym / sponsor ID
- KD019-207
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor opened Phase 2 Study.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Kadmon Corporation, LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Dec 2015
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects who received tesevatinib in Study KD019-101 and completed 24 months of treatment will continue on the dose of tesevatinib they were receiving at 24 months on the KD019-101 study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Extension Study, participants to be followed at the dose of tesevatinib they were receiving in Study KD019-101.
| Arm | Type | Receives |
|---|---|---|
| 50mg Daily | Experimental | Drug: tesevatinibOne 50mg tesevatinib tablet per day |
| 100mg Daily | Experimental | Drug: tesevatinibTwo 50mg tesevatinib tablets per day |
| 150mg M/Th | Experimental | Drug: tesevatinibThree 50mg tesevatinib tablets every Monday and Thursday. |
| 150mg MWF | Experimental | Drug: tesevatinibThree 50mg tesevatinib tablets every Monday, Wednesday and Friday. |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The subject must have received 24 months of treatment with tesevatinib on study KD019-101. (Twenty-four months of study drug treatment includes days without treatment that were allowed by the KD019-101 protocol.)
- Sexually active subject (male and female) has agreed to use two forms of accepted methods of contraception during the course of the study and for 3 months after the last dose of study drug. Effective birth control includes (a) IUD plus one barrier method; (b) on stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method; or (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm).
- Female subjects of childbearing potential have a negative pregnancy test at screening. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tesevatinibAlso: KD019, XL647 | Drug | 100mg Daily, 150mg M/Th, 150mg MWF, 50mg Daily |
Primary outcome
Monitor Longitudinal Changes in Estimated Glomerular Filtration Rate
Time frame: 37 Months
Monitor longitudinal changes in estimated glomerular filtration rate (eGFR) in subjects with ADPKD when treated with tesevatinib.
2 secondary outcomes
Monitor Longitudinal Changes in Total Kidney Volume
Time frame: 37 Months
Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability
Time frame: 37 Months
Results and safety
The study was stopped early (reason given: Sponsor opened Phase 2 Study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
Related trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Active, not recruitingObservational study
Role of ROS and cAMP-PKA Biomarkers in ADPKD
Autosomal Dominant Polycystic Kidney Disease
Not yet recruitingPhase 1
A Study to Investigate the Pharmacokinetics of JMKX003142 in Healthy Participants and Participants With Hepatic Impairment
ADPKD (Autosomal Dominant Polycystic Kidney Disease), Renal Edema
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Active, not recruitingObservational study
Polycystic Kidney Disease 1 (PKD1) Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tesevatinib in people with Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Kadmon Corporation, LLC at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor opened Phase 2 Study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitor Longitudinal Changes in Estimated Glomerular Filtration Rate (time frame: 37 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.