← Back to Search

Vasopressin V2 Receptor Antagonist

Lixivaptan for Polycystic Kidney Disease (ALERT Trial)

Phase 3
Waitlist Available
Led By Arlene Chapman, MD
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 up to 62 weeks
Awards & highlights

ALERT Trial Summary

This trial is designed to test the safety and efficacy of lixivaptan in subjects who were previously treated with tolvaptan and permanently discontinued from the drug due to liver chemistry test abnormalities. Up to 50 subjects will be enrolled and treated with lixivaptan for 52 weeks.

Eligible Conditions
  • Polycystic Kidney Disease

ALERT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 62 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 62 weeks 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 Alanine Aminotransferase (ALT) Levels >3 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Discontinuation of Lixivaptan Treatment
Secondary outcome measures
Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Final Assessment
Number of Participants Who Develop Serum ALT Levels >3 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Dose Reduction of Lixivaptan Treatment
Number of Participants Who Develop Serum ALT Levels >5 × ULN During the Titration or Maintenance Periods Assessed to be Related to Lixivaptan and Result in Discontinuation of Lixivaptan Treatment
+4 more

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

ALERT Trial Design

1Treatment groups
Experimental Treatment
Group I: LixivaptanExperimental Treatment1 Intervention
Lixivaptan oral capsules, 100-200 mg 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?

Centessa Pharmaceuticals plcIndustry Sponsor
8 Previous Clinical Trials
509 Total Patients Enrolled
Palladio BiosciencesLead Sponsor
4 Previous Clinical Trials
44 Total Patients Enrolled
Arlene Chapman, MDPrincipal InvestigatorUniversity of Chicago, Chicago, IL USA
1 Previous Clinical Trials
624 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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
Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease
2020. "Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04152837.
~2 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top