Trial Outcomes & Findings for Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease (NCT NCT04064346)

NCT ID: NCT04064346

Last Updated: 2023-02-06

Results Overview

The annualized change in eGFR will be calculated from the Chronic Kidney Disease Epidemiology Collaboration eGFR creatinine equation refit without the race variable (CKD-EPIcr\_R) equation for serum creatinine from baseline (mean of 3 eGFR determinations obtained during Screening and Placebo Run-in Periods \[Visits 1a/1b (if required), Visit 2, and Visit 3\]) to final assessment (mean of 3 eGFR determinations obtained during Follow-up Period I or, for participants who discontinue treatment prior to Visit 22, during the Follow-up Period 8 to 28 days following study drug treatment discontinuation).

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 12 participants
• Primary outcome timeframe: Baseline to the end of Follow-up Period I (up to 71 weeks)
• Results posted on: 2023-02-06

Participant Flow

Participant milestones

Measure	All Subjects Pre-randomization After meeting entry criteria during screening, the single-blind pre-randomization period (up to 7 weeks) consisted of: 1. A 1-week single-blind, Placebo Run-in Period during which participants self-administered 4 capsules containing placebo twice daily for 1 week. 2. A 5- to 6-week single-blind dose titration period during which lixivaptan administered twice daily (BID) was titrated to the highest tolerated dose (the Lixivaptan Titration Period).	Lixivaptan Randomized Double-blind Period (52 weeks): Participants in this group successfully titrated and tolerated the drug were randomized to continue receiving lixivaptan at the dose level achieved at the end of the Lixivaptan Titration Period.	Placebo Randomized Double-blind Period (52 weeks): Participants in this group successfully titrated and tolerated the drug were randomized to receive placebo matched to the dose level of lixivaptan achieved at the end of the Lixivaptan Titration Period.
Pre-randomization Single-blind Period STARTED	12	0	0
Pre-randomization Single-blind Period Treated in Placebo Run-in	12	0	0
Pre-randomization Single-blind Period Treated in Lixivaptan Titration Period	8	0	0
Pre-randomization Single-blind Period COMPLETED	5	0	0
Pre-randomization Single-blind Period NOT COMPLETED	7	0	0
Randomized Double-blind Period STARTED	0	4	1
Randomized Double-blind Period Randomized	0	4	1
Randomized Double-blind Period COMPLETED	0	4	1
Randomized Double-blind Period NOT COMPLETED	0	0	0
Follow-up Period I STARTED	0	3	1
Follow-up Period I COMPLETED	0	3	1
Follow-up Period I NOT COMPLETED	0	0	0
Re-titration Period STARTED	0	0	0
Re-titration Period COMPLETED	0	0	0
Re-titration Period NOT COMPLETED	0	0	0
Maintenance Treatment Period STARTED	0	0	0
Maintenance Treatment Period COMPLETED	0	0	0
Maintenance Treatment Period NOT COMPLETED	0	0	0
Follow-up Period II STARTED	0	0	0
Follow-up Period II COMPLETED	0	0	0
Follow-up Period II NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease

Baseline characteristics by cohort

Measure	All Enrolled Participants n=12 Participants The baseline population consisted of all enrolled participants.
Age, Continuous	44.9 Years STANDARD_DEVIATION 8.40 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Region of Enrollment Bulgaria	2 participants n=5 Participants
Body Mass Index	28.47 kg/m^2 STANDARD_DEVIATION 6.795 • n=5 Participants
Family History of Autosomal Dominant Polycystic Kidney Disease Yes	10 Participants n=5 Participants
Family History of Autosomal Dominant Polycystic Kidney Disease No	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to the end of Follow-up Period I (up to 71 weeks)

Population: Efficacy data were not analyzed as only 5 participants were randomized, and all 5 participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization. One month after randomization was the first scheduled post-randomization visit during which efficacy parameters would have been collected.

The annualized change in eGFR will be calculated from the Chronic Kidney Disease Epidemiology Collaboration eGFR creatinine equation refit without the race variable (CKD-EPIcr_R) equation for serum creatinine from baseline (mean of 3 eGFR determinations obtained during Screening and Placebo Run-in Periods [Visits 1a/1b (if required), Visit 2, and Visit 3]) to final assessment (mean of 3 eGFR determinations obtained during Follow-up Period I or, for participants who discontinue treatment prior to Visit 22, during the Follow-up Period 8 to 28 days following study drug treatment discontinuation).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline to the end of Follow-up Period II (up to 64 weeks)

Population: Efficacy data were not analyzed as only 5 participants were randomized, and all 5 participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization. One month after randomization was the first scheduled post-randomization visit during which efficacy parameters would have been collected. The study terminated prior to any participants entering Part 2 of study.

The annualized change in eGFR will be calculated from the CKD-EPIcr_R equation for serum creatinine from baseline (mean of 3 eGFR determinations obtained during obtained during Follow-up Period I) to final assessment (mean of 3 eGFR determinations obtained during Follow-up Period II or, for participants who discontinue treatment prior to Visit 43, during the Follow-up Period 8 to 28 days following study drug treatment discontinuation).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the end of the Single-blind Lixivaptan Titration Period to the end of Follow-up Period I (maximum of 102 days)

Population: All participants who entered the Double-blind Randomized Treatment Period.

Number of participants randomized to lixivaptan with serum ALT levels >3 × the ULN compared to those randomized to placebo. The normal range of ALT was defined as 0-33 or 0-44 U/L, depending on the lab used.

Outcome measures

Measure	Lixivaptan n=4 Participants Lixivaptan capsules, 100-200 mg twice a day (BID) Lixivaptan: Oral vasopressin V2 receptor antagonist	Placebo n=1 Participants Matching placebo capsules BID Placebo: Matching placebo
Number of Participants With Serum Alanine Aminotransferase (ALT) Levels >3 × the Upper Limit of Normal (ULN) - Part 1	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Duration of the Lixivaptan Re-titration Period and the Maintenance Treatment Period (56 weeks) and Follow-up Period II (4 weeks)

Population: The study terminated prior to any participants entering Part 2 of study.

Number of participants randomized to lixivaptan with serum ALT levels >3 × ULN compared to those randomized to placebo. The normal range of ALT was defined as 0-33 or 0-44 U/L, depending on the lab used.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to the end of Double-blind Randomized Treatment Period (up to 67 weeks), with changes from baseline calculated every 4 weeks during the Double-blind Randomized Treatment Period

Population: Efficacy data were not analyzed as only 5 participants were randomized, and all 5 participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization. One month after randomization was the first scheduled post-randomization visit during which efficacy parameters would have been collected.

Annualized rate of change (slope) in eGFR for serum creatinine, based on all eGFR determinations from baseline to all visits with on-treatment eGFR values during the Double-blind, Randomized Treatment Period. The baseline value will be calculated as the mean of 3 eGFR determinations obtained during Screening and Placebo Run-in Periods (Visits 1a/1b [if required], Visit 2, and Visit 3).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to the end of the Maintenance Treatment Period (up to 60 weeks), with changes from baseline calculated every 4 weeks during the Maintenance Treatment Period

Population: Efficacy data were not analyzed as only 5 participants were randomized, and all 5 participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization. One month after randomization was the first scheduled post-randomization visit during which efficacy parameters would have been collected. The study terminated prior to any participants entering Part 2 of study.

Annualized rate of change (slope) in eGFR for serum creatinine, based on all eGFR determinations from baseline to all visits with on-treatment eGFR values during the Maintenance Treatment Period. The baseline value will be calculated as the mean of 3 eGFR determinations obtained during obtained during Follow-up Period I.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to the end of Follow-up Period I (up to 71 weeks)

Population: Efficacy data were not analyzed as only 5 participants were randomized, and all 5 participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization. One month after randomization was the first scheduled post-randomization visit during which efficacy parameters would have been collected.

Annualized percent change in htTKV, determined by magnetic resonance imaging (MRI), from baseline (obtained at Screening [Visit 1a]) to the end of Follow-up Period I.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to the end of Follow-up Period II (up to 60 weeks)

Population: Efficacy data were not analyzed as only 5 participants were randomized, and all 5 participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization. One month after randomization was the first scheduled post-randomization visit during which efficacy parameters would have been collected. The study terminated prior to any participants entering Part 2 of study.

Annualized percent change in htTKV, determined by MRI from baseline (obtained at Visit 25/Week 56) to the end of Follow-up Period II.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: All participants entering the Lixivaptan Titration Period.

Number of participants with TEAEs during the Lixivaptan Titration Period.

Outcome measures

Measure	Lixivaptan n=8 Participants Lixivaptan capsules, 100-200 mg twice a day (BID) Lixivaptan: Oral vasopressin V2 receptor antagonist	Placebo Matching placebo capsules BID Placebo: Matching placebo
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Lixivaptan Titration Period in Part 1	3 Participants	—

SECONDARY outcome

Timeframe: From Randomization to study completion (up to 102 days)

Population: All participants who were randomized.

Number of participants with TEAEs by treatment group after Randomization (Double-blind Randomized Treatment Period and Follow-up Period I)

Outcome measures

Measure	Lixivaptan n=4 Participants Lixivaptan capsules, 100-200 mg twice a day (BID) Lixivaptan: Oral vasopressin V2 receptor antagonist	Placebo n=1 Participants Matching placebo capsules BID Placebo: Matching placebo
Number of Participants With TEAEs After Randomization in Part 1	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 60 weeks

Population: All participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization; none proceeded to Part 2 of the study.

Number of participants with TEAEs by treatment cohort during Part 2 (Lixivaptan Re-titration Period, Maintenance Treatment Period, and Follow-up Period II).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: All participants entering the Lixivaptan Titration Period.

Number of participants with clinical laboratory findings (clinical chemistry, hematology and urinalysis) recorded during the Lixivaptan Titration Period and considered to be potentially clinically important.

Outcome measures

Measure	Lixivaptan n=8 Participants Lixivaptan capsules, 100-200 mg twice a day (BID) Lixivaptan: Oral vasopressin V2 receptor antagonist	Placebo Matching placebo capsules BID Placebo: Matching placebo
Number of Participants With Potentially Clinically Important Clinical Laboratory Findings During the Lixivaptan Titration Period in Part 1	0 Participants	—

SECONDARY outcome

Timeframe: From Randomization to last clinical laboratory evaluation (up to 102 days)

Population: All participants who were randomized.

Number of participants with clinical laboratory findings (clinical chemistry, hematology and urinalysis) recorded after Randomization (Double-blind Randomized Treatment Period and Follow-up Period I) and considered to be potentially clinically important, by treatment group.

Outcome measures

Measure	Lixivaptan n=4 Participants Lixivaptan capsules, 100-200 mg twice a day (BID) Lixivaptan: Oral vasopressin V2 receptor antagonist	Placebo n=1 Participants Matching placebo capsules BID Placebo: Matching placebo
Number of Participants With Potentially Clinically Important Clinical Laboratory Findings After Randomization in Part 1	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 60 weeks

Population: All participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization; none proceeded to Part 2 of the study.

Number of participants with clinical laboratory findings (clinical chemistry, hematology and urinalysis) recorded during Part 2 (Lixivaptan Re-titration Period, Maintenance Treatment Period, and Follow-up Period II) and considered to be potentially clinically important, by treatment cohort.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: All participants entering the Lixivaptan Titration Period.

Number of participants with vital signs findings (heart rate, diastolic and systolic blood pressure, weight) recorded during the Lixivaptan Titration Period and considered to be potentially clinically important.

Outcome measures

Measure	Lixivaptan n=8 Participants Lixivaptan capsules, 100-200 mg twice a day (BID) Lixivaptan: Oral vasopressin V2 receptor antagonist	Placebo Matching placebo capsules BID Placebo: Matching placebo
Number of Participants With Potentially Clinically Important Vital Signs Findings During the Lixivaptan Titration Period in Part 1	0 Participants	—

SECONDARY outcome

Timeframe: From Randomization to last measurement of vital signs (up to 102 days)

Population: All participants who were randomized.

Number of participants with vital signs findings (heart rate, diastolic and systolic blood pressure, weight) recorded after Randomization (Double-blind Randomized Treatment Period and Follow-up Period I) and considered to be potentially clinically important, by treatment group.

Outcome measures

Measure	Lixivaptan n=4 Participants Lixivaptan capsules, 100-200 mg twice a day (BID) Lixivaptan: Oral vasopressin V2 receptor antagonist	Placebo n=1 Participants Matching placebo capsules BID Placebo: Matching placebo
Number of Participants With Potentially Clinically Important Vital Signs Findings After Randomization in Part 1	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 60 weeks

Population: All participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization; none proceeded to Part 2 of the study.

Number of participants with vital signs findings (heart rate, diastolic and systolic blood pressure, weight) recorded during Part 2 (Lixivaptan Re-titration Period, Maintenance Treatment Period, and Follow-up Period II) and considered to be potentially clinically important, by treatment cohort.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: All participants entering the Lixivaptan Titration Period.

Number of participants with ECG findings recorded during the Lixivaptan Titration 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).

Outcome measures

Measure	Lixivaptan n=8 Participants Lixivaptan capsules, 100-200 mg twice a day (BID) Lixivaptan: Oral vasopressin V2 receptor antagonist	Placebo Matching placebo capsules BID Placebo: Matching placebo
Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Findings During the Lixivaptan Titration Period in Part 1	0 Participants	—

SECONDARY outcome

Timeframe: From Randomization to last ECG (up to 102 days)

Population: All participants who were randomized.

Number of participants with ECG findings recorded after Randomization (Double-blind Randomized Treatment Period and Follow-up Period I) and considered to be potentially clinically important (defined as a QTcF ≥ 450 msec), by treatment group.

Outcome measures

Measure	Lixivaptan n=4 Participants Lixivaptan capsules, 100-200 mg twice a day (BID) Lixivaptan: Oral vasopressin V2 receptor antagonist	Placebo n=1 Participants Matching placebo capsules BID Placebo: Matching placebo
Number of Participants With Potentially Clinically Significant 12-lead ECG Findings After Randomization in Part 1	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 60 weeks

Population: All participants were prematurely terminated from the study drug by the sponsor less than 1 month following randomization; none proceeded to Part 2 of the study.

Number of participants with ECG findings recorded during Part 2 (Lixivaptan Re-titration Period, Maintenance Treatment Period, and Follow-up Period II) and considered to be potentially clinically important (defined as a QTcF ≥ 450 msec), by treatment cohort.

Outcome measures

Outcome data not reported

Adverse Events

Lixivaptan Titration Period

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Lixivaptan (Randomized Treatment Period)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo (Randomized Treatment Period)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lixivaptan Titration Period n=8 participants at risk All participants who took at least one dose of lixivaptan during the Lixivaptan Titration Period in Part 1	Lixivaptan (Randomized Treatment Period) n=4 participants at risk Lixivaptan capsules, 100-200 mg twice a day (BID) Lixivaptan: Oral vasopressin V2 receptor antagonist	Placebo (Randomized Treatment Period) n=1 participants at risk Matching placebo capsules BID Placebo: Matching placebo
Gastrointestinal disorders Abdominal distension	12.5% 1/8 • Number of events 1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/4 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)
Gastrointestinal disorders Diarrhoea	12.5% 1/8 • Number of events 1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/4 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)
Infections and infestations Nasopharyngitis	12.5% 1/8 • Number of events 1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/4 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)
Investigations Influenza A virus test positive	12.5% 1/8 • Number of events 1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/4 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)
Metabolism and nutrition disorders Polydipsia	12.5% 1/8 • Number of events 1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/4 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)
Nervous system disorders Headache	12.5% 1/8 • Number of events 4 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/4 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)
Renal and urinary disorders Polyuria	12.5% 1/8 • Number of events 1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/4 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)
Renal and urinary disorders Renal cyst ruptured	12.5% 1/8 • Number of events 1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/4 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)
Vascular disorders Hypertension	25.0% 2/8 • Number of events 2 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/4 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)
Eye disorders Dry eye	0.00% 0/8 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	25.0% 1/4 • Number of events 1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)
Investigations Transaminases increased	0.00% 0/8 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/4 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	100.0% 1/1 • Number of events 1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)
Renal and urinary disorders Acute kidney injury	0.00% 0/8 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	25.0% 1/4 • Number of events 1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)
Vascular disorders Hypotension	0.00% 0/8 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	25.0% 1/4 • Number of events 1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)	0.00% 0/1 • Adverse events were recorded from when participants had taken their first dose of lixivaptan in the Lixivaptan Titration Period until the end of the study (maximum duration: 123 days)

Additional Information

Milena Kanova

Centessa Pharmaceuticals

Phone: +44 7780 430583

Email: milena.kanova@centessa.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60