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Vasopressin V2 Receptor Antagonist

Lixivaptan for Polycystic Kidney Disease (ACTION Trial)

Phase 3
Waitlist Available
Led By Vicente Torres, MD, PhD
Research Sponsored by Palladio Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of ADPKD by appropriate imaging or genetic testing.
eGFR ≥25 mL/min/1.73 m2 and ≤90 mL/min/1.73 m^2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to the end of double-blind randomized treatment period (up to 67 weeks), with changes from baseline calculated every 4 weeks during the double-blind randomized treatment period
Awards & highlights

ACTION Trial Summary

This trial is testing a drug to see if it can help people with a kidney disease called polycystic kidney disease (ADPKD). The trial has two parts. In the first part, the people taking the drug are compared with people taking a fake (placebo) drug to see if the drug works. In the second part, everyone takes the drug to see if it is safe and if it works for a long time.

Eligible Conditions
  • Polycystic Kidney Disease

ACTION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

ACTION Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to the end of double-blind randomized treatment period (up to 67 weeks), with changes from baseline calculated every 4 weeks during the double-blind randomized treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to the end of double-blind randomized treatment period (up to 67 weeks), with changes from baseline calculated every 4 weeks during the double-blind randomized treatment 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
Annualized Change in Estimated Glomerular Filtration Rate (eGFR) - Part 1
Annualized Change in Estimated Glomerular Filtration Rate (eGFR) - Part 2
Secondary outcome measures
Height-adjusted Total Kidney Volume (htTKV) - Part 1
Height-adjusted Total Kidney Volume (htTKV) - Part 2
Number of Participants With Potentially Clinically Important Clinical Laboratory Findings After Randomization in Part 1
+15 more

Side effects data

From 2020 Phase 2 trial • 31 Patients • NCT03487913
11%
Flank pain
11%
Nausea
11%
Urinary tract infection
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

ACTION Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LixivaptanExperimental Treatment1 Intervention
Lixivaptan capsules, 100-200 mg twice a day (BID)
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo capsules BID
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
39 Total Patients Enrolled
Centessa Pharmaceuticals plcIndustry Sponsor
8 Previous Clinical Trials
504 Total Patients Enrolled
Vicente Torres, MD, PhDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
1,491 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Mar 2025