Status:
TERMINATED
Roll-over Study to Assess Safety of Lixivaptan in Participants With ADPKD Who Completed Study PA-ADPKD-303
Lead Sponsor:
Palladio Biosciences
Collaborating Sponsors:
Centessa Pharmaceuticals plc
Conditions:
Polycystic Kidney Disease, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 abnorm...
Detailed Description
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 abnorm...
Eligibility Criteria
Inclusion
- 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
- Willing to practice acceptable methods of birth control (both males who have partners of child-bearing potential and females of childbearing potential).
- Able to provide informed consent.
Exclusion
- 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 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values \>1.5 × ULN
- Total bilirubin values \>1.5 × ULN
- eGFR \<20 mL/min/1.73 m\^2 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
Key Trial Info
Start Date :
February 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT05208866
Start Date
February 10 2022
End Date
July 29 2022
Last Update
May 12 2023
Active Locations (1)
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1
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, United States, 18107