Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease
Public ClinicalTrials.gov record NCT04064346. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants With Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase and a 1-year Open-label Phase: The ACTION Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3 trial consisting of a 2-arm, double-blind, placebo-controlled, randomized phase (Part 1) followed by a single-arm open-label phase (Part 2) to demonstrate the efficacy and safety of lixivaptan in participants with autosomal dominant polycystic kidney disease (ADPKD). Part 1 of the trial is designed to demonstrate the efficacy of lixivaptan in slowing the decline in kidney function as measured by the difference in estimated glomerular filtration rate (eGFR) between the lixivaptan-treated and placebo-treated participants. Part 2 of the study is designed to provide confirmation of the durability of this effect. Additionally, both parts of the study will contribute to understanding the safety of lixivaptan, particularly any effects on liver chemistry tests.
Study identification
- NCT ID
- NCT04064346
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 28, 2021 (Actual)
- Primary completion
- Aug 3, 2022 (Actual)
- Completion
- Aug 3, 2022 (Actual)
- Last update posted
- Feb 6, 2023
2021 – 2022
United States locations
- U.S. sites
- 23
- U.S. states
- 14
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Nephrology Associates, PC - Greystone | Hoover | Alabama | 35242 | — |
| Nephrology Consultants, LLC | Huntsville | Alabama | 35805-4104 | — |
| Arizona Kidney Disease & Hypertension Center - Scottsdale / Pima | Scottsdale | Arizona | 85258 | — |
| JEM Research Institute | Atlantis | Florida | 33462 | — |
| Elixia at Florida Kidney Physicians - Southeast | Fort Lauderdale | Florida | 33308 | — |
| Qway Research | Hialeah | Florida | 33010 | — |
| South Florida Nephrology Associates PA | Lauderdale Lakes | Florida | 33313-1600 | — |
| Total Research Group, LLC | Miami | Florida | 33126 | — |
| Innovation Medical Research Center, Inc | Palmetto Bay | Florida | 33157 | — |
| Florida Kidney Physicians - Tampa | Tampa | Florida | 33615 | — |
| Clinical Site Partners, LLC | Winter Park | Florida | 32789 | — |
| Tufts Medical Center, Inc, | Boston | Massachusetts | 02111 | — |
| St Clair Nephrology Research, LLC | Roseville | Michigan | 48066 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Clinical Research Consultants, LLC | Kansas City | Missouri | 64111 | — |
| Angel City Research, Inc | Morrisville | North Carolina | 27560 | — |
| Northeast Clinical Research Center, LLC | Bethlehem | Pennsylvania | 18107 | — |
| Brown Medicine - Brown Physicians Patient Center | Riverside | Rhode Island | 02915-2235 | — |
| Knoxville Kidney Center LLC | Knoxville | Tennessee | 37923 | — |
| Prolato Clinical Research Center (PCRC) | Houston | Texas | 77054-2854 | — |
| Clinical Advancement Center, PLLC | San Antonio | Texas | 78212 | — |
| Utah Kidney Research Institute | Salt Lake City | Utah | 84115 | — |
| Nephrology Associates of Northern Virginia, Inc | Fairfax | Virginia | 22033 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04064346, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 6, 2023 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04064346 live on ClinicalTrials.gov.