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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

Summary

This trial tests lixivaptan in patients with ADPKD who had liver problems with another drug. It aims to see if lixivaptan is safe for the liver and effective for the kidneys. Another drug has been used to slow the progression of kidney disease in ADPKD but is associated with significant liver injury.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 study objectives
Estimated Glomerular Filtration Rate (eGFR)

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

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
9 Previous Clinical Trials
665 Total Patients Enrolled
Nelson Kopyt, DOPrincipal InvestigatorNortheast Clinical Research Center, LLC
~0 spots leftby Sep 2025
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