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

NCT05208866 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-05-12

Study results available
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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.

Conditions

  • Polycystic Kidney Disease, Adult

Interventions

DRUG

Lixivaptan

Oral vasopressin V2 receptor antagonist

Sponsors & Collaborators

  • Centessa Pharmaceuticals plc

    collaborator INDUSTRY

  • Palladio Biosciences

    lead INDUSTRY

Principal Investigators

  • Nelson Kopyt, DO · Northeast Clinical Research Center, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2022-06-29
Completion
2022-07-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05208866 on ClinicalTrials.gov