Your session is about to expire
← Back to Search
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 belowACTION Trial Timeline
Screening ~ 3 weeks3 visits
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
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
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 moreSide effects data
From 2020 Phase 2 trial • 31 Patients • NCT0348791311%
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.
Recent research and studies
Share this study with friends
Copy Link
Messenger