Trial · NCT03487913
The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
NCT03487913, Phase 2, Completed, Palladio Biosciences; results first posted 2022-12-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease. Trials, record NCT03487913. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03487913
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
- NCT number
- NCT03487913
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Palladio Biosciences
- Conditions
- Autosomal Dominant Polycystic Kidney Disease
- Interventions
- Lixivaptan
- First posted
- 2018-04-04
- Last updated
- 2022-12-05
- Results first posted
- 2022-12-05
Source ClinicalTrials.gov
Registered outcomes55
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Lixivaptan in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The pharmacokinetic parameter Cmax, the highest concentration of lixivaptan measured in plasma after multiple doses of drug, will be calculated from the observed concentration of lixivaptan and summarized by cohort. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of WAY-141624 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The pharmacokinetic parameter Cmax, the highest concentration of WAY-141624 measured in plasma after multiple doses of drug, will be calculated from the observed concentration of WAY-141624 and summarized by cohort. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of WAY-138451 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The pharmacokinetic parameter Cmax, the highest concentration of WAY-138451 measured in plasma after multiple doses of drug, will be calculated from the observed concentration of WAY-138451 and summarized by cohort. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of WAY-138758 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The pharmacokinetic parameter Cmax, the highest concentration of WAY-138758 measured in plasma after multiple doses of drug, will be calculated from the observed concentration of WAY-138758 and summarized by cohort. |
| Primary | Time to Reach Maximum Plasma Concentration (Tmax) of Lixivaptan in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The pharmacokinetic parameter tmax, the time taken to reach the highest concentration of lixivaptan in plasma after multiple doses of drug, will be calculated from the observed concentration of lixivaptan and summarized by cohort. |
| Primary | Time to Reach Maximum Plasma Concentration (Tmax) of WAY-141624 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The pharmacokinetic parameter tmax, the time taken to reach the highest concentration of WAY-141624 in plasma after multiple doses of drug, will be calculated from the observed concentration of WAY-141624 and summarized by cohort. |
| Primary | Time to Reach Maximum Plasma Concentration (Tmax) of WAY-138451 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The pharmacokinetic parameter tmax, the time taken to reach the highest concentration of WAY-138451 in plasma after multiple doses of drug, will be calculated from the observed concentration of WAY-138451 and summarized by cohort. |
| Primary | Time to Reach Maximum Plasma Concentration (Tmax) of WAY-138758 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The pharmacokinetic parameter tmax, the time taken to reach the highest concentration of WAY-138758 in plasma after multiple doses of drug, will be calculated from the observed concentration of WAY-138758 and summarized by cohort. |
| Primary | Area Under the Concentration-time Curve From Time 0 Until the Last Quantifiable Concentration (AUC[0-last]) of Lixivaptan in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The pharmacokinetic parameter AUC(0-last) for lixivaptan will be calculated using the linear trapezoidal rule for increasing values and the log trapezoidal rule for decreasing values, summarized by cohort. |
| Primary | Area Under the Concentration-time Curve From Time 0 Until the Last Quantifiable Concentration (AUC[0-last]) of WAY-141624 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The pharmacokinetic parameter AUC(0-last) for WAY-141624 will be calculated using the linear trapezoidal rule for increasing values and the log trapezoidal rule for decreasing values and summarized by cohort. |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 registered outcomesOutcomes55
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of Lixivaptan in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Of these, all 31 subjects contributed to the PK data on Day 1 (am); 30 contributed data to Day 1 (pm); and 29 contributed data to Day 7 (am) and (pm). | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of WAY-141624 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Missing values and substantial deviations from planned dosing interval durations meant results were excluded from subjects at various time points. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of WAY-138451 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Missing values, substantial deviations, and \<3 quantifiable postdose WAY-138451 concentrations meant results were excluded from subjects at various time points. | ng/mL | GEOMETRIC_LEAST_SQUARES_MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of WAY-138758 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Of these, all 31 subjects contributed to the PK data on Day 1 (am); 30 contributed data to Day 1 (pm); and 29 contributed data to Day 7 (am) and (pm). Substantial deviations from planned dosing interval durations meant additional results were excluded from subjects at various time points. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Time to Reach Maximum Plasma Concentration (Tmax) of Lixivaptan in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Of these, all 31 subjects contributed to the PK data on Day 1 (am); 30 contributed data to Day 1 (pm); and 29 contributed data to Day 7 (am) and (pm). Substantial deviations from planned dosing interval durations meant results were excluded from subjects at various time points. | hours | MEDIAN |
| PRIMARY | Time to Reach Maximum Plasma Concentration (Tmax) of WAY-141624 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Missing values and substantial deviations from planned dosing interval durations meant results were excluded from subjects at various time points. | hours | MEDIAN |
| PRIMARY | Time to Reach Maximum Plasma Concentration (Tmax) of WAY-138451 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Missing values, substantial deviations from planned dosing interval durations, and \<3 quantifiable postdose WAY-138451 concentrations meant results were excluded from subjects at various time points. | hours | MEDIAN |
| PRIMARY | Time to Reach Maximum Plasma Concentration (Tmax) of WAY-138758 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. All 31 subjects in the PKAS contributed to the PK data on Day 1 (am); 30 contributed data to Day 1 (pm); and 29 contributed data to Day 7 (am) and (pm). Substantial deviations from planned dosing interval durations and missing values meant results were excluded from subjects at various time points. | hours | MEDIAN |
| PRIMARY | Area Under the Concentration-time Curve From Time 0 Until the Last Quantifiable Concentration (AUC[0-last]) of Lixivaptan in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. All 31 subjects in the PKAS contributed to the PK data on Day 1 (am); 30 contributed data to Day 1 (pm); 29 contributed data to Day 7 (am), and 27 contributed data to Day 7 (pm). Substantial deviations from planned dosing interval durations and missing values meant results were excluded from subjects at various time points. | ng*hour/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration-time Curve From Time 0 Until the Last Quantifiable Concentration (AUC[0-last]) of WAY-141624 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Missing values and substantial deviations from planned dosing interval durations meant results were excluded from subjects at various time points. | ng*hour/mL | GEOMETRIC_MEAN |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 outcomesResults by group521
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Lixivaptan in ADPKD Patients | High Dose Lixivaptan / CKD1 or CKD2 | Day 1 (am) | 656.8 | Geometric Coefficient of Variation 28.1 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of Lixivaptan in ADPKD Patients | Low Dose Lixivaptan / CKD1 or CKD2 | Day 1 (am) | 190.9 | Geometric Coefficient of Variation 52.0 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of Lixivaptan in ADPKD Patients | High Dose Lixivaptan / CKD3 | Day 1 (am) | 681.3 | Geometric Coefficient of Variation 45.9 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of Lixivaptan in ADPKD Patients | Low Dose Lixivaptan / CKD3 | Day 1 (am) | 156.9 | Geometric Coefficient of Variation 66.9 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of Lixivaptan in ADPKD Patients | High Dose Lixivaptan / CKD1 or CKD2 | Day 1 (pm) | 1007 | Geometric Coefficient of Variation 36.6 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of Lixivaptan in ADPKD Patients | Low Dose Lixivaptan / CKD1 or CKD2 | Day 1 (pm) | 211.5 | Geometric Coefficient of Variation 33.5 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of Lixivaptan in ADPKD Patients | High Dose Lixivaptan / CKD3 | Day 1 (pm) | 930.2 | Geometric Coefficient of Variation 44.5 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of Lixivaptan in ADPKD Patients | Low Dose Lixivaptan / CKD3 | Day 1 (pm) | 159.5 | Geometric Coefficient of Variation 51.9 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of Lixivaptan in ADPKD Patients | High Dose Lixivaptan / CKD1 or CKD2 | Day 7 (am) | 1442 | Geometric Coefficient of Variation 34.3 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of Lixivaptan in ADPKD Patients | Low Dose Lixivaptan / CKD1 or CKD2 | Day 7 (am) | 339.5 | Geometric Coefficient of Variation 19.5 | ng/mL |
1 to 10 of 521Source ClinicalTrials.gov
See all 521 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | High Dose Lixivaptan / CKD1 or CKD2 | 9 | |
| Overall Study | STARTED | Low Dose Lixivaptan / CKD1 or CKD2 | 7 | |
| Overall Study | STARTED | High Dose Lixivaptan / CKD3 | 8 | |
| Overall Study | STARTED | Low Dose Lixivaptan / CKD3 | 7 | |
| Overall Study | COMPLETED | High Dose Lixivaptan / CKD1 or CKD2 | 9 | |
| Overall Study | COMPLETED | Low Dose Lixivaptan / CKD1 or CKD2 | 7 | |
| Overall Study | COMPLETED | High Dose Lixivaptan / CKD3 | 8 | |
| Overall Study | COMPLETED | Low Dose Lixivaptan / CKD3 | 7 | |
| Overall Study | NOT COMPLETED | High Dose Lixivaptan / CKD1 or CKD2 | 0 | |
| Overall Study | NOT COMPLETED | Low Dose Lixivaptan / CKD1 or CKD2 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events92
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 | Dry mouth | Gastrointestinal disorders | High Dose Lixivaptan / CKD1 or CKD2 | 0 | 9 | 0 |
| other | Dry mouth | Gastrointestinal disorders | Low Dose Lixivaptan / CKD1 or CKD2 | 2 | 7 | 2 |
| other | Dry mouth | Gastrointestinal disorders | High Dose Lixivaptan / CKD3 | 1 | 8 | 1 |
| other | Dry mouth | Gastrointestinal disorders | Low Dose Lixivaptan / CKD3 | 0 | 7 | 0 |
| other | Nausea | Gastrointestinal disorders | High Dose Lixivaptan / CKD1 or CKD2 | 1 | 9 | 1 |
| other | Nausea | Gastrointestinal disorders | Low Dose Lixivaptan / CKD1 or CKD2 | 0 | 7 | 0 |
| other | Nausea | Gastrointestinal disorders | High Dose Lixivaptan / CKD3 | 0 | 8 | 0 |
| other | Nausea | Gastrointestinal disorders | Low Dose Lixivaptan / CKD3 | 2 | 7 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | High Dose Lixivaptan / CKD1 or CKD2 | 0 | 9 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Low Dose Lixivaptan / CKD1 or CKD2 | 0 | 7 | 0 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High Dose Lixivaptan / CKD1 or CKD2 | 0 | 9 |
| Total, all-cause mortality | Low Dose Lixivaptan / CKD1 or CKD2 | 0 | 7 |
| Total, all-cause mortality | High Dose Lixivaptan / CKD3 | 0 | 8 |
| Total, all-cause mortality | Low Dose Lixivaptan / CKD3 | 0 | 7 |
| Total, other adverse events | High Dose Lixivaptan / CKD1 or CKD2 | 2 | 9 |
| Total, other adverse events | Low Dose Lixivaptan / CKD1 or CKD2 | 4 | 7 |
| Total, other adverse events | High Dose Lixivaptan / CKD3 | 4 | 8 |
| Total, other adverse events | Low Dose Lixivaptan / CKD3 | 4 | 7 |
| Total, serious adverse events | High Dose Lixivaptan / CKD1 or CKD2 | 0 | 9 |
| Total, serious adverse events | Low Dose Lixivaptan / CKD1 or CKD2 | 0 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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.
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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