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Clinical trialNCT04064346TerminatedPhase 3Interventional

Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease

SponsorPalladio BiosciencesEnrollment12ADPKDAutosomal Dominant Polycystic Kidney
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

43 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Renal Research - Gosford

    Gosford, New South Wales, Australia

Bulgaria
  • University Multiprofile Hospital for Active Treatment

    Pleven, Bulgaria

  • Medical Center "hipokrat - N"

    Plovdiv, Bulgaria

  • University Multiprofile Hospital for Active Treatment - Kaspela

    Plovdiv, Bulgaria

  • Kidney Center - Medical Center

    Varna, Bulgaria

  • Multi-Profile Hospital for Active Treatment Sveta Anna - Varna

    Varna, Bulgaria

Hungary
  • Bajai Szent Rokus Korhaz

    Baja, Hungary

  • Semmelweis Egyetem

    Budapest, Hungary

  • Debreceni Egyetem

    Debrecen, Hungary

  • Bugat Pal Korhaz

    Gyöngyös, Hungary

  • University of Pecs

    Pécs, Hungary

Poland
  • Scm Spolka Z O.O

    Krakow, Poland

  • Provita Centrum Medyczne Sp. Z O.O.

    Warsaw, Poland

Spain
  • Hospital Universitari de Bellvitge (hub)

    Barcelona, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Spain

Turkey (Türkiye)
  • T.R. Ministry of Health Ankara Training and Research Hospital (internal Disease, Division of Nephrology)

    Ankara, Turkey (Türkiye)

  • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

    Fatih, Turkey (Türkiye)

  • Istanbul Universitesi - Cerrahpasa Tip Fakultesi Hastanesi (iuctfh)

    Fatih, Turkey (Türkiye)

  • Erciyes Universitesi Tip Fakultesi (erciyes University Faculty of Medicine) (internal Medicine; Nephrology)

    Kayseri, Turkey (Türkiye)

United Kingdom
  • Salford Royal Nhs Foundation Trust

    Salford, United Kingdom

United States
  • Nephrology Associates, Pc - Greystone

    Hoover, Alabama, United States

  • Nephrology Consultants, Llc

    Huntsville, Alabama, United States

  • Arizona Kidney Disease & Hypertension Center - Scottsdale / Pima

    Scottsdale, Arizona, United States

  • Jem Research Institute

    Atlantis, Florida, United States

  • Elixia at Florida Kidney Physicians - Southeast

    Fort Lauderdale, Florida, United States

  • Qway Research

    Hialeah, Florida, United States

  • South Florida Nephrology Associates Pa

    Lauderdale Lakes, Florida, United States

  • Total Research Group, Llc

    Miami, Florida, United States

  • Innovation Medical Research Center, Inc

    Palmetto Bay, Florida, United States

  • Florida Kidney Physicians - Tampa

    Tampa, Florida, United States

  • Clinical Site Partners, Llc

    Winter Park, Florida, United States

  • Tufts Medical Center, Inc,

    Boston, Massachusetts, United States

  • St Clair Nephrology Research, Llc

    Roseville, Michigan, United States

  • Mayo Clinic

    Rochester, Minnesota, United States

  • Clinical Research Consultants, Llc

    Kansas City, Missouri, United States

  • Angel City Research, Inc

    Morrisville, North Carolina, United States

  • Northeast Clinical Research Center, Llc

    Bethlehem, Pennsylvania, United States

  • Brown Medicine - Brown Physicians Patient Center

    Riverside, Rhode Island, United States

  • Knoxville Kidney Center Llc

    Knoxville, Tennessee, United States

  • Prolato Clinical Research Center (pcrc)

    Houston, Texas, United States

3 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

LIXIVAPTANPlacebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
28 Oct 2021
Primary completion
3 Aug 2022
Completion
3 Aug 2022
Last update posted
6 Feb 2023
Registered enrollment
12
Registry id
NCT04064346
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.