Lixivaptan ( DrugBank: Lixivaptan )


1 disease
IDDisease name (Link within this page)Number of trials
67Polycystic kidney disease11

67. Polycystic kidney disease


Clinical trials : 221 Drugs : 212 - (DrugBank : 55) / Drug target genes : 40 - Drug target pathways : 151
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-003062-12-SK
(EUCTR)
11/03/202216/11/2021A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment.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. - ACTION Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Lixivaptan
Product Code: 0C23
INN or Proposed INN: Lixivaptan
Other descriptive name: Lixivaptan
Palladio Biosciences Inc.,NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1350Phase 3Portugal;Belarus;Serbia;United States;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Australia;Denmark;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;New Zealand
2EUCTR2021-003062-12-PL
(EUCTR)
24/02/202223/11/2021A clinical trial to look at how safe and how effective Lixivaptan in patients with kidney disease compared to a placebo treatment.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. - ACTION Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Lixivaptan
Product Code: 0C23
INN or Proposed INN: Lixivaptan
Other descriptive name: Lixivaptan
Palladio Biosciences Inc.,NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Israel;Chile;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Georgia;Bulgaria
3NCT05208866
(ClinicalTrials.gov)
February 10, 20227/1/2022Roll-over Study to Assess Safety of Lixivaptan in Participants With ADPKD Who Completed Study PA-ADPKD-303PA-ADPKD-304: A Phase 3, Open-label, Roll-over Study to Assess Long-term Safety of Lixivaptan in Participants With Autosomal Dominant Polycystic Kidney Disease Who Completed Study PA-ADPKD-303: The ALERT StudyPolycystic Kidney Disease, AdultDrug: LixivaptanPalladio BiosciencesCentessa Pharmaceuticals plcTerminated18 YearsN/AAll1Phase 3United States
4EUCTR2021-003062-12-BG
(EUCTR)
09/02/202206/12/2021A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment.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. - ACTION Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Lixivaptan
Product Code: 0C23
INN or Proposed INN: Lixivaptan
Other descriptive name: Lixivaptan
Palladio Biosciences Inc.,NULLNot RecruitingFemale: yes
Male: yes
1350Phase 3Serbia;United States;Portugal;Slovakia;Spain;Ukraine;Israel;Chile;Colombia;Italy;France;Peru;Australia;Denmark;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;New Zealand
5EUCTR2021-003062-12-ES
(EUCTR)
21/01/202220/10/2021A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment.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. - ACTION Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Lixivaptan
Product Code: 0C23
INN or Proposed INN: Lixivaptan
Other descriptive name: Lixivaptan
Palladio Biosciences Inc.,NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia
6EUCTR2021-003062-12-IT
(EUCTR)
20/01/202218/10/2021A clinical trial to look at how safe and how effective Lixivaptan in patients with kidney disease compared to a placebo treatment.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. - ACTION Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Lixivaptan
Product Code: [0C23]
INN or Proposed INN: Lixivaptan
Palladio Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia
7EUCTR2021-003062-12-HU
(EUCTR)
03/01/202205/11/2021A clinical trial to look at how safe and how effective Lixivaptan is in patients with kidney disease compared to a placebo treatment.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. - ACTION Autosomal Dominant Polycystic Kidney Disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: Lixivaptan
Product Code: 0C23
INN or Proposed INN: Lixivaptan
Other descriptive name: Lixivaptan
Palladio Biosciences Inc.,NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Peru;Bulgaria;Georgia
8NCT04064346
(ClinicalTrials.gov)
October 28, 202119/8/2019Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney DiseaseA 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 StudyAutosomal Dominant Polycystic Kidney;ADPKDDrug: Lixivaptan;Drug: PlaceboPalladio BiosciencesCentessa Pharmaceuticals plcTerminated18 Years60 YearsAll12Phase 3United States;Australia;Bulgaria;Hungary;Poland;Spain;Turkey;United Kingdom;Argentina;Canada;Chile;Israel;Italy;Mexico;Romania;Slovakia
9NCT04152837
(ClinicalTrials.gov)
September 2, 202031/10/2019Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney DiseaseAn Open-Label Study of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Who Previously Experienced Abnormal Liver Chemistry Test Results While Receiving Tolvaptan: The ALERT StudyPolycystic Kidney Disease, Adult;ADPKDDrug: LixivaptanPalladio BiosciencesCentessa Pharmaceuticals plcTerminated18 Years65 YearsAll7Phase 3United States
10NCT03717181
(ClinicalTrials.gov)
February 19, 201922/10/2018Lixivaptan in a Single Subject With Intractable Pain Due to Polycystic Kidney DiseaseExpanded Access Use of Lixivaptan in a Single Subject With Intractable Pain Due to Polycystic Kidney DiseasePolycystic KidneyDrug: LixivaptanPalladio BiosciencesNULLNo longer available15 Years60 YearsAllUnited States
11NCT03487913
(ClinicalTrials.gov)
September 14, 201816/3/2018The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney DiseaseA Phase 2, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: LixivaptanPalladio BiosciencesNULLCompleted18 Years65 YearsAll31Phase 2United States