Trial · NCT04152837
Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease
NCT04152837, 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. Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease. Trials, record NCT04152837. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04152837
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease
- NCT number
- NCT04152837
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 7 participants, actual
- Lead sponsor
- Palladio Biosciences
- Conditions
- Polycystic Kidney Disease, Adult, ADPKD
- Interventions
- Lixivaptan
- First posted
- 2019-11-05
- Last updated
- 2023-04-10
- 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 Alanine Aminotransferase (ALT) Levels >3 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Discontinuation of Lixivaptan Treatment | Up to 58 weeks | Number of participants who develop serum ALT levels \>3 x ULN which are assessed by the independent Hepatic Events Review Committee (HERC) to be at least probably related to lixivaptan and result in the 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 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Discontinuation of Lixivaptan Treatment | Up to 58 weeks | Number of participants who develop serum ALT levels \>5 x ULN which are assessed by the independent HERC to be at least probably related to lixivaptan and result in the 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 >3 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Dose Reduction of Lixivaptan Treatment | Up to 58 weeks | Number of participants who develop serum ALT levels \>3 x ULN which are assessed by the independent HERC to be at least probably related to lixivaptan and result in the 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) | Up to 62 weeks | Number of participants with TEAEs during the Titration Period, the Maintenance Period, or the Follow-up Period. |
| Secondary | Number of Participants With Potentially Clinically Important Clinical Laboratory Findings | Up to 62 weeks | Number of participants with clinical laboratory findings (non-hepatic clinical chemistry, hematology, and urinalysis) recorded during the Titration Period, the Maintenance Period, or the Follow-up Period, and considered to be potentially clinically important. |
| Secondary | Number of Participants With Potentially Clinically Important Vital Signs Findings | Up to 62 weeks | Number of participants with vital signs findings (heart rate, diastolic and systolic blood pressure, weight) recorded during the Titration Period, the Maintenance 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 | Up to 62 weeks | Number of participants with ECG findings recorded during the Titration Period, the Maintenance 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 | Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Final Assessment | Up to 62 weeks | Baseline eGFR is defined as the mean of the 3 eGFR assessments obtained during the Baseline Period (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 Alanine Aminotransferase (ALT) Levels >3 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Discontinuation of Lixivaptan Treatment | Up to 58 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Develop Serum ALT Levels >5 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Discontinuation of Lixivaptan Treatment | Up to 58 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Develop Serum ALT Levels >3 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Dose Reduction of Lixivaptan Treatment | Up to 58 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 62 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Potentially Clinically Important Clinical Laboratory Findings | Up to 62 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Potentially Clinically Important Vital Signs Findings | Up to 62 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Potentially Clinically Important 12-lead Electrocardiogram (ECG) Findings | Up to 62 weeks | The same participant experienced potentially clinically important ECG findings in the Baseline Period, in addition to during the Titration and Maintenance, and Follow-up Periods. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Final Assessment | Up to 62 weeks | mL/min/1.73m^2 | MEAN |
Source ClinicalTrials.gov
Results by group13
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 Alanine Aminotransferase (ALT) Levels >3 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Discontinuation of Lixivaptan Treatment | Lixivaptan: Titration and Maintenance Periods | 1 | Participants | ||
| Number of Participants Who Develop Serum ALT Levels >5 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Discontinuation of Lixivaptan Treatment | Lixivaptan: Titration and Maintenance Periods | 1 | Participants | ||
| Number of Participants Who Develop Serum ALT Levels >3 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Dose Reduction of Lixivaptan Treatment | Lixivaptan: Titration and Maintenance Periods | 0 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Lixivaptan: Titration, Maintenance, and Follow-up Periods | Titration and Maintenance Periods | 6 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Lixivaptan: Titration, Maintenance, and Follow-up Periods | Follow-up Period | 1 | Participants | |
| Number of Participants With Potentially Clinically Important Clinical Laboratory Findings | Lixivaptan: Titration, Maintenance, and Follow-up Periods | Titration and Maintenance Periods | 1 | Participants | |
| Number of Participants With Potentially Clinically Important Clinical Laboratory Findings | Lixivaptan: Titration, Maintenance, and Follow-up Periods | Follow-up Period | 0 | Participants | |
| Number of Participants With Potentially Clinically Important Vital Signs Findings | Lixivaptan: Titration, Maintenance, and Follow-up Periods | Titration and Maintenance Periods | 5 | Participants | |
| Number of Participants With Potentially Clinically Important Vital Signs Findings | Lixivaptan: Titration, Maintenance, and Follow-up Periods | Follow-up Period | 0 | Participants | |
| Number of Participants With Potentially Clinically Important 12-lead Electrocardiogram (ECG) Findings | Lixivaptan: Titration, Maintenance, and Follow-up Periods | Baseline Period | 1 | Participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline Period (No Treatment) | STARTED | Lixivaptan | 7 | |
| Baseline Period (No Treatment) | COMPLETED | Lixivaptan | 6 | |
| Baseline Period (No Treatment) | NOT COMPLETED | Lixivaptan | 1 | |
| Titration Period | STARTED | Lixivaptan | 6 | |
| Titration Period | COMPLETED | Lixivaptan | 6 | |
| Titration Period | NOT COMPLETED | Lixivaptan | 0 | |
| Maintenance Period | STARTED | Lixivaptan | 6 | |
| Maintenance Period | COMPLETED | Lixivaptan | 2 | |
| Maintenance Period | NOT COMPLETED | Lixivaptan | 4 | |
| Follow-up Period | STARTED | Lixivaptan | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events60
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 | Abdominal pain | Gastrointestinal disorders | Titration and Maintenance Periods | 1 | 6 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Follow-up Period | 0 | 6 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Titration and Maintenance Periods | 1 | 6 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Follow-up Period | 0 | 6 | 0 |
| other | Constipation | Gastrointestinal disorders | Titration and Maintenance Periods | 1 | 6 | 1 |
| other | Constipation | Gastrointestinal disorders | Follow-up Period | 0 | 6 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | Titration and Maintenance Periods | 1 | 6 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Follow-up Period | 0 | 6 | 0 |
| other | Nausea | Gastrointestinal disorders | Titration and Maintenance Periods | 1 | 6 | 1 |
| other | Nausea | Gastrointestinal disorders | Follow-up Period | 0 | 6 | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Titration and Maintenance Periods | 0 | 6 |
| Total, all-cause mortality | Follow-up Period | 0 | 6 |
| Total, other adverse events | Titration and Maintenance Periods | 6 | 6 |
| Total, other adverse events | Follow-up Period | 1 | 6 |
| Total, serious adverse events | Titration and Maintenance Periods | 2 | 6 |
| Total, serious adverse events | Follow-up Period | 0 | 6 |
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/NCT04152837
GET https://conductscience.org/api/trials/v1/NCT04152837/events?page=2