Trial · NCT03203642
Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD
NCT03203642, Phase 2, Completed, Kadmon, a Sanofi Company; results first posted 2023-02-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD. Trials, record NCT03203642. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03203642
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD
- NCT number
- NCT03203642
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- Kadmon, a Sanofi Company
- Conditions
- Autosomal Dominant Polycystic Kidney, ADPKD
- Interventions
- Tesevatinib, Placebo
- First posted
- 2017-06-29
- Last updated
- 2023-02-06
- Results first posted
- 2023-02-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Height Adjusted Total Kidney Volume (htTKV) at Month 12 | Baseline (Day 1), Month 12 | htTKV was calculated using total kidney volume (in milliliters) obtained from magnetic resonance imaging (MRI) divided by height (in meters). Least square (LS) mean and standard error (SE) were estimated by using analysis of covariance (ANCOVA) model. Change from Baseline in htTKV at Month 12 was reported in this outcome measure. |
| Primary | Change From Baseline in Height Adjusted Total Kidney Volume at Month 18 | Baseline (Day 1), Month 18 | htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at Month 18 was reported in this outcome measure. |
| Primary | Change From Baseline in Height Adjusted Total Kidney Volume at Month 24 | Baseline (Day 1), Month 24 | htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at Month 24 was reported in this outcome measure. |
| Primary | Change From Baseline in Height Adjusted Total Kidney Volume at End of Study | Baseline (Day 1), End of study (anytime up to 26 months) | htTKV was calculated using total kidney volume (in milliliters) obtained from MRI divided by height (in meters). LS mean and SE were estimated by using ANCOVA model. Change from Baseline in htTKV at end of study (i.e., up to 26 months) was reported in this outcome measure. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From Baseline (Day 1) up to 30 days post last dose of study drug (i.e., up to 26 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. TEAEs were AEs that developed or worsened or became serious from the first dose (Day 1) of the study drug until end of study. |
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 18, 24 and End of Study | Baseline (Day 1), Months 12, 18, 24 and at end of study (i.e., anytime up to 26 months) | eGFR is a test for renal function. eGFR was calculated by using the 4-variable modification of diet in renal disease (MDRD-4) formula reported as milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2). LS mean and SE were estimated using ANCOVA model. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Height Adjusted Total Kidney Volume (htTKV) at Month 12 | Baseline (Day 1), Month 12 | Analysis was performed on efficacy population which included all randomized participants who received at least 1 dose of study drug and completed at least 12 months of tesevatinib or placebo treatment and had a centrally read MRI at Baseline and after 12 months of treatment. | milliliters per meter | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Height Adjusted Total Kidney Volume at Month 18 | Baseline (Day 1), Month 18 | Analysis was performed on efficacy population. | milliliters per meter | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Height Adjusted Total Kidney Volume at Month 24 | Baseline (Day 1), Month 24 | Analysis was performed on efficacy population. | milliliters per meter | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Height Adjusted Total Kidney Volume at End of Study | Baseline (Day 1), End of study (anytime up to 26 months) | Analysis was performed on efficacy population. | milliliters per meter | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From Baseline (Day 1) up to 30 days post last dose of study drug (i.e., up to 26 months) | Analysis was performed on safety population which included all participants who received at least 1 dose of study drug and were analyzed according to the study drug they actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 18, 24 and End of Study | Baseline (Day 1), Months 12, 18, 24 and at end of study (i.e., anytime up to 26 months) | Analysis was performed on efficacy population. | mL/min/1.73m^2 | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Height Adjusted Total Kidney Volume (htTKV) at Month 12 | Tesevatinib | 0.0236 | Standard Error 0.0059 | milliliters per meter | |
| Change From Baseline in Height Adjusted Total Kidney Volume (htTKV) at Month 12 | Placebo | 0.0288 | Standard Error 0.0057 | milliliters per meter | |
| Change From Baseline in Height Adjusted Total Kidney Volume at Month 18 | Tesevatinib | 0.0383 | Standard Error 0.0081 | milliliters per meter | |
| Change From Baseline in Height Adjusted Total Kidney Volume at Month 18 | Placebo | 0.0425 | Standard Error 0.0075 | milliliters per meter | |
| Change From Baseline in Height Adjusted Total Kidney Volume at Month 24 | Tesevatinib | 0.0485 | Standard Error 0.0103 | milliliters per meter | |
| Change From Baseline in Height Adjusted Total Kidney Volume at Month 24 | Placebo | 0.0607 | Standard Error 0.0095 | milliliters per meter | |
| Change From Baseline in Height Adjusted Total Kidney Volume at End of Study | Tesevatinib | 0.0604 | Standard Error 0.0090 | milliliters per meter | |
| Change From Baseline in Height Adjusted Total Kidney Volume at End of Study | Placebo | 0.0589 | Standard Error 0.0094 | milliliters per meter | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Tesevatinib | 37 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Placebo | 40 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tesevatinib | 40 | |
| Overall Study | STARTED | Placebo | 40 | |
| Overall Study | Treated | Tesevatinib | 38 | |
| Overall Study | Treated | Placebo | 40 | |
| Overall Study | COMPLETED | Tesevatinib | 25 | |
| Overall Study | COMPLETED | Placebo | 29 | |
| Overall Study | NOT COMPLETED | Tesevatinib | 15 | |
| Overall Study | NOT COMPLETED | Placebo | 11 |
Source ClinicalTrials.gov
Adverse events218
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 | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Tesevatinib | 21 | 38 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 13 | 40 | |
| other | Nausea | Gastrointestinal disorders | Tesevatinib | 14 | 38 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 6 | 40 | |
| other | Vomiting | Gastrointestinal disorders | Tesevatinib | 7 | 38 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 5 | 40 | |
| other | Dyspepsia | Gastrointestinal disorders | Tesevatinib | 5 | 38 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 5 | 40 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Tesevatinib | 3 | 38 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 4 | 40 |
1 to 10 of 218Source ClinicalTrials.gov
See all 218 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tesevatinib | 0 | 38 |
| Total, all-cause mortality | Placebo | 0 | 40 |
| Total, other adverse events | Tesevatinib | 37 | 38 |
| Total, other adverse events | Placebo | 40 | 40 |
| Total, serious adverse events | Tesevatinib | 6 | 38 |
| Total, serious adverse events | Placebo | 2 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41385299 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tesevatinib vs Placebo: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
| Tesevatinib vs Placebo: deaths from any cause | Trial comparisons |
| Tesevatinib vs Placebo: serious adverse events | Trial comparisons |
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03203642
GET https://conductscience.org/api/trials/v1/NCT03203642/events?page=2