Trial · NCT05208866
Roll-over Study to Assess Safety of Lixivaptan in Participants With ADPKD Who Completed Study PA-ADPKD-303
NCT05208866, Phase 3, Terminated, Palladio Biosciences; results first posted 2023-04-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Roll-over Study to Assess Safety of Lixivaptan in Participants With ADPKD Who Completed Study PA-ADPKD-303. Trials, record NCT05208866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05208866
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Roll-over Study to Assess Safety of Lixivaptan in Participants With ADPKD Who Completed Study PA-ADPKD-303
- NCT number
- NCT05208866
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1 participants, actual
- Lead sponsor
- Palladio Biosciences
- Conditions
- Polycystic Kidney Disease, Adult
- Interventions
- Lixivaptan
- First posted
- 2022-01-26
- Last updated
- 2023-05-12
- Results first posted
- 2023-04-10
- Limitations and caveats
- Efficacy and safety results are limited by the early termination of the trial and the small number of subjects. Early termination was due to a sponsor decision for reasons unrelated to safety.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Develop Serum ALT Levels >3 × ULN During the Lixivaptan Re-titration or Maintenance Treatment Periods Assessed to be Related to Lixivaptan and Resulted in Discontinuation of Lixivaptan Treatment | 120 days (from Screening to the end of the Maintenance Treatment Period) | Number of participants who develop serum alanine aminotransferase (ALT) levels \>3 × the upper limit of normal (ULN) which are assessed by the independent Hepatic Events Review Committee (HERC) to be at least probably related to lixivaptan and resulted in discontinuation of lixivaptan treatment. The independent HERC, after reviewing demographic, medical and medication history, safety data and other relevant data of participants who develop liver abnormalities, will determine the probable causality for liver chemistry test abnormalities of concern and the relatedness to lixivaptan using the Drug-Induced Liver Injury Network probability criteria (Fontana et al., 2009). The normal range of ALT was defined as 0-55 U/L. |
| Secondary | Number of Participants Who Develop Serum ALT Levels >5 x ULN During the Lixivaptan Re-titration or Maintenance Treatment Periods Assessed to be Related to Lixivaptan and Resulted in Discontinuation of Lixivaptan Treatment | 120 days (from Screening to the end of the Maintenance Treatment Period) | Number of participants who develop serum ALT levels \>5 × ULN which are assessed by the independent HERC to be at least probably related to lixivaptan and resulted in discontinuation of lixivaptan treatment. The independent HERC, after reviewing demographic, medical and medication history, safety data and other relevant data of participants who develop liver abnormalities, will determine the probable causality for liver chemistry test abnormalities of concern and the relatedness to lixivaptan using the Drug-Induced Liver Injury Network probability criteria (Fontana et al., 2009). The normal range of ALT was defined as 0-55 U/L. |
| Secondary | Number of Participants Who Develop Serum ALT Values >3 × ULN During the Lixivaptan Re-titration or Maintenance Treatment Periods Assessed to be Related to Lixivaptan and Resulted in Dose Reduction of Lixivaptan Treatment | 120 days (from Screening to the end of the Maintenance Treatment Period) | Number of participants who develop serum ALT levels \>3 × ULN that were assessed by the independent HERC to be at least probably related to lixivaptan and resulted in dose reduction of lixivaptan treatment. The independent HERC, after reviewing demographic, medical and medication history, safety data and other relevant data of participants who develop liver abnormalities, will determine the probable causality for liver chemistry test abnormalities of concern and the relatedness to lixivaptan using the Drug-Induced Liver Injury Network probability criteria (Fontana et al., 2009). The normal range of ALT was defined as 0-55 U/L. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 140 days (from Screening to the end of the Follow-up Period) | Number of participants with TEAEs during the Lixivaptan Re-titration Period, the Maintenance Treatment Period, or the Follow-up Period. |
| Secondary | Number of Participants With Potentially Clinically Important Clinical Laboratory Findings | 140 days (from Screening to the end of the Follow-up Period) | Number of participants with clinical laboratory findings (non-hepatic clinical chemistry, hematology, and urinalysis) recorded during the Lixivaptan Re-titration Period, the Maintenance Treatment Period, or the Follow-up Period, and considered to be potentially clinically important. |
| Secondary | Number of Participants With Potentially Clinically Important Vital Signs Findings | 140 days (from Screening to the end of the Follow-up Period) | Number of participants with vital signs findings (heart rate, diastolic and systolic blood pressure, and weight) recorded during the Lixivaptan Re-titration Period, the Maintenance Treatment Period, or the Follow-up Period, and considered to be potentially clinically important. |
| Secondary | Number of Participants With Potentially Clinically Important 12-lead Electrocardiogram (ECG) Findings | 140 days (from Screening to the end of the Follow-up Period) | Number of participants with ECG findings recorded during the Lixivaptan Re-titration Period, the Maintenance Treatment Period, or the Follow-up Period, and considered to be potentially clinically important (defined as a QT interval corrected for heart rate according to Fridericia's formula \[QTcF\] ≥ 450 msec). |
| Secondary | Annualized Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Final Assessment | 140 days (from Screening to the end of the Follow-up Period) | Baseline eGFR is defined as the mean of the 3 eGFR assessments obtained at Visits 25, 26 and 27 of study PA-ADPKD-303 (if any values are missing, the remaining values will be used to determine the baseline eGFR). The endpoint eGFR is defined as the mean of 3 eGFR assessments obtained during the Follow-up Period (if any values are missing, the remaining values will be used to determine the endpoint eGFR). The change in eGFR from Baseline to Final Assessment will be provided. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Develop Serum ALT Levels >3 × ULN During the Lixivaptan Re-titration or Maintenance Treatment Periods Assessed to be Related to Lixivaptan and Resulted in Discontinuation of Lixivaptan Treatment | 120 days (from Screening to the end of the Maintenance Treatment Period) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Develop Serum ALT Levels >5 x ULN During the Lixivaptan Re-titration or Maintenance Treatment Periods Assessed to be Related to Lixivaptan and Resulted in Discontinuation of Lixivaptan Treatment | 120 days (from Screening to the end of the Maintenance Treatment Period) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Develop Serum ALT Values >3 × ULN During the Lixivaptan Re-titration or Maintenance Treatment Periods Assessed to be Related to Lixivaptan and Resulted in Dose Reduction of Lixivaptan Treatment | 120 days (from Screening to the end of the Maintenance Treatment Period) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 140 days (from Screening to the end of the Follow-up Period) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Potentially Clinically Important Clinical Laboratory Findings | 140 days (from Screening to the end of the Follow-up Period) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Potentially Clinically Important Vital Signs Findings | 140 days (from Screening to the end of the Follow-up Period) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Potentially Clinically Important 12-lead Electrocardiogram (ECG) Findings | 140 days (from Screening to the end of the Follow-up Period) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Annualized Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Final Assessment | 140 days (from Screening to the end of the Follow-up Period) | The annualized change in eGRF is provided for the only participant enrolled at the time of early termination of the study. | mL/min/1.73m^2 | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Participants Who Develop Serum ALT Levels >3 × ULN During the Lixivaptan Re-titration or Maintenance Treatment Periods Assessed to be Related to Lixivaptan and Resulted in Discontinuation of Lixivaptan Treatment | All Enrolled Participants | 0 | Participants | ||
Number of Participants Who Develop Serum ALT Levels >5 x ULN During the Lixivaptan Re-titration or Maintenance Treatment Periods Assessed to be Related to Lixivaptan and Resulted in Discontinuation of Lixivaptan Treatment | All Enrolled Participants | 0 | Participants | ||
Number of Participants Who Develop Serum ALT Values >3 × ULN During the Lixivaptan Re-titration or Maintenance Treatment Periods Assessed to be Related to Lixivaptan and Resulted in Dose Reduction of Lixivaptan Treatment | All Enrolled Participants | 0 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | All Enrolled Participants | Lixivaptan Re-titration and Maintenance Treatment Periods | 1 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | All Enrolled Participants | Follow-up Period | 0 | Participants | |
| Number of Participants With Potentially Clinically Important Clinical Laboratory Findings | All Enrolled Participants | Lixivaptan Re-titration and Maintenance Treatment Periods | 0 | Participants | |
| Number of Participants With Potentially Clinically Important Clinical Laboratory Findings | All Enrolled Participants | Follow-up Period | 0 | Participants | |
| Number of Participants With Potentially Clinically Important Vital Signs Findings | All Enrolled Participants | Lixivaptan Re-titration and Maintenance Treatment Periods | 0 | Participants | |
| Number of Participants With Potentially Clinically Important Vital Signs Findings | All Enrolled Participants | Follow-up Period | 0 | Participants | |
| Number of Participants With Potentially Clinically Important 12-lead Electrocardiogram (ECG) Findings | All Enrolled Participants | Lixivaptan Re-titration and Maintenance Treatment Periods | 0 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Lixivaptan Re-titration Period | STARTED | All Enrolled Participants | 1 | |
| Lixivaptan Re-titration Period | COMPLETED | All Enrolled Participants | 1 | |
| Lixivaptan Re-titration Period | NOT COMPLETED | All Enrolled Participants | 0 | |
| Maintenance Treatment Period | STARTED | All Enrolled Participants | 1 | |
| Maintenance Treatment Period | COMPLETED | All Enrolled Participants | 0 | |
| Maintenance Treatment Period | NOT COMPLETED | All Enrolled Participants | 1 | |
| Follow-up Period | STARTED | All Enrolled Participants | 1 | |
| Follow-up Period | COMPLETED | All Enrolled Participants | 1 | |
| Follow-up Period | NOT COMPLETED | All Enrolled Participants | 0 |
Source ClinicalTrials.gov
Adverse events4
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 | Dermatitis contact | Skin and subcutaneous tissue disorders | Titration and Maintenance Periods | 1 | 1 | 1 |
| other | Dermatitis contact | Skin and subcutaneous tissue disorders | Follow-up Period | 0 | 1 | 0 |
| other | Arthropod bite | Injury, poisoning and procedural complications | Titration and Maintenance Periods | 1 | 1 | 1 |
| other | Arthropod bite | Injury, poisoning and procedural complications | Follow-up Period | 0 | 1 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Titration and Maintenance Periods | 0 | 1 |
| Total, all-cause mortality | Follow-up Period | 0 | 1 |
| Total, other adverse events | Titration and Maintenance Periods | 1 | 1 |
| Total, other adverse events | Follow-up Period | 0 | 1 |
| Total, serious adverse events | Titration and Maintenance Periods | 0 | 1 |
| Total, serious adverse events | Follow-up Period | 0 | 1 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19132805 | BACKGROUND |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Titration and Maintenance Periods vs Follow-up Period: deaths from any cause | Trial comparisons |
| Titration and Maintenance Periods vs Follow-up Period: 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/NCT05208866
GET https://conductscience.org/api/trials/v1/NCT05208866/registered