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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 140 days (from screening to the end of the follow-up period)

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)