← Back to Search

Vasopressin V2 Receptor Antagonist

Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant 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
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests lixivaptan in patients who had liver issues with a previous treatment. The study aims to find a safe and effective dose of lixivaptan by carefully adjusting the dose and regularly checking health, especially liver function.

Eligible Conditions
  • Polycystic Kidney Disease

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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%
Nausea
11%
Flank pain
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
9 Previous Clinical Trials
659 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
~1 spots leftby Dec 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