Open-label, Roll-over Study to Assess Safety of Lixivaptan in Participants With ADPKD Who Completed Study PA-ADPKD-303

• Status: Not yet recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 3, open-label, roll-over study to demonstrate the continued hepatic and non-hepatic safety and renal efficacy of lixivaptan in participants with ADPKD who previously experienced abnormal liver chemistry test results while treated with tolvaptan, were permanently discontinued from the drug for that reason, and subsequently completed study PA-ADPKD-303, the open-label lead-in study with lixivaptan.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Palladio Biosciences

Criteria

Inclusion Criteria:

• Male or female participants with ADPKD who completed study PA-ADPKD-303

• Continued control of hypertension without the use of a diuretic

• Continued adherence to prohibitions on concomitant medications stated in the study PA-ADPKD-303 protocol

Exclusion Criteria:

• Any contraindication to continued treatment with lixivaptan

• Clinically significant incontinence, overactive bladder, or urinary retention (e.g., benign prostatic hyperplasia)

• New York Heart Association Functional Class 3 or 4 heart failure or other significant cardiac or electrocardiogram (ECG) findings that could pose a safety risk to the participant

• Hypovolemia on physical examination at Screening

• The following laboratory results based on serum drawn at Visit 24 of PA-ADPKD-303:

Serum ALT or aspartate aminotransferase (AST) values >1.5 × upper limit of normal (ULN)

Total bilirubin values >1.5 × ULN

• eGFR <20 ml/min/1.73 m2 based on laboratory results from Visit 26 of PA-ADPKD-303

• A finding at Screening that precludes safe participation in the study or participants who are likely to be non-compliant with study procedures in the opinion of the Investigator or medical monitor