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Vasopressin V2 Receptor Antagonist

Lixivaptan for Polycystic Kidney Disease

Phase 3
Waitlist Available
Led By Nelson Kopyt, DO
Research Sponsored by Palladio Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 140 days (from screening to the end of the follow-up period)
Awards & highlights

Study 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.

Eligible Conditions
  • Polycystic Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~140 days (from screening to the end of the follow-up period)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 140 days (from screening to the end of the follow-up period) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Develop Serum ALT Levels >3 × ULN During the Lixivaptan Re-titration or Maintenance Treatment Periods Assessed to be Related to Lixivaptan and Resulted in Discontinuation of Lixivaptan Treatment
Secondary outcome measures
Annualized Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Final Assessment
Number of Participants Who Develop Serum ALT Levels >5 x ULN During the Lixivaptan Re-titration or Maintenance Treatment Periods Assessed to be Related to Lixivaptan and Resulted in Discontinuation of Lixivaptan Treatment
Number of Participants Who Develop Serum ALT Values >3 × ULN During the Lixivaptan Re-titration or Maintenance Treatment Periods Assessed to be Related to Lixivaptan and Resulted in Dose Reduction of Lixivaptan Treatment
+4 more
Other outcome measures
Estimated Glomerular Filtration Rate (eGFR)

Side effects data

From 2020 Phase 2 trial • 31 Patients • NCT03487913
11%
Urinary tract infection
11%
Flank pain
11%
Nausea
11%
Paraesthesia
100%
80%
60%
40%
20%
0%
Study treatment Arm
High Dose Lixivaptan / CKD1 or CKD2
Low Dose Lixivaptan / CKD1 or CKD2
High Dose Lixivaptan / CKD3
Low Dose Lixivaptan / CKD3

Trial Design

1Treatment groups
Experimental Treatment
Group I: LixivaptanExperimental Treatment1 Intervention
Lixivaptan capsules 100-200mg twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lixivaptan
2010
Completed Phase 3
~410

Find a Location

Who is running the clinical trial?

Palladio BiosciencesLead Sponsor
4 Previous Clinical Trials
50 Total Patients Enrolled
Centessa Pharmaceuticals plcIndustry Sponsor
8 Previous Clinical Trials
515 Total Patients Enrolled
Nelson Kopyt, DOPrincipal InvestigatorNortheast Clinical Research Center, LLC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
Drug SafetyJournal
Drug-induced Liver Injury Network (DILIN) Prospective Study
Fontana, Robert J., Paul B. Watkins, Herbert L. Bonkovsky, Naga Chalasani, Timothy Davern, Jose Serrano, and James Rochon. 2009. “Drug-induced Liver Injury Network (DILIN) Prospective Study”. Drug Safety. Springer Science and Business Media LLC. doi:10.2165/00002018-200932010-00005.
clinicaltrials.govStudy
Roll-over Study to Assess Safety of Lixivaptan in Participants With ADPKD Who Completed Study PA-ADPKD-303
2022. "Roll-over Study to Assess Safety of Lixivaptan in Participants With ADPKD Who Completed Study PA-ADPKD-303". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05208866.
~0 spots leftby Apr 2025
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