Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT05208866
Eligibility 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
* 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 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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05208866
Study Brief:
Protocol Section:
NCT05208866